Implant system · Nobel Biocare

NobelActive

Partially verifiedLast verified 27 Sept 2026 · data version 1

Quick answer

NobelActive is a dental implant system from Nobel Biocare (Nobel Biocare Services AG, part of Envista). It is made of commercially pure titanium with a TiUltra™ (current) surface and uses a internal conical connection with hex interface connection. We link 5 FDA 510(k) records to this system. Open any value below to see its source.

Brand and system alone do not decide how an implant does. Bone, gum health, smoking, the surgeon's skill, the restoration and maintenance all matter. How to compare implant systems →

Manufacturer

Brand: Nobel Biocare
Manufacturer (regulatory name): Nobel Biocare Services AG
Corporate group: Envista
Headquarters country: Switzerland (headquarters, not necessarily the place of manufacture)
Status: Currently marketed
Also known as: Nobel Active, NobelActive TiUltra, NobelActive TiUnite, Nobel Active implant

Implant type

Implant levelWhere the top of the implant sits: level with the bone, or higher up in the gum.	Bone level (submerged-type root-form) FDA summary describes a threaded root-form implant; explicit 'bone level' wording to be confirmed from current IFU. Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Body shapeThe overall shape of the screw that goes into the jaw.	Expanding taper body Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)

Material & surface

MaterialWhat the implant screw itself is made of.	Commercially pure titanium Titanium grade (reported as grade 4 in the TiUltra IFU) not yet confirmed by direct IFU reading — shown as not verified. Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Material grade	Not verified
SurfaceHow the outer surface is treated so bone can grow onto it.	TiUltra™ (current); TiUnite® on earlier NobelActive implants FDA K202344 describes a surface treatment that preserves hydrophilicity (anodization-based with a protective salt layer). Regulatory recordManufacturer documentation3 sources · verified 27 Sept 2026 FDA 510(k) K202344 — TiUltra Implants and Xeal Abutments (510(k) summary) (2020) FDA 510(k) K142260 — NobelActive (510(k) summary) (2015) Conical connection implants & prosthetics — Product overview (86168 B GB 1906) (2019)

Connection

ConnectionHow the visible tooth part (abutment) attaches to the implant.	Internal conical connection with hex interface Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K202344 — TiUltra Implants and Xeal Abutments (510(k) summary) (2020) Differently described in another source: Internal hex The 2015 FDA summary classifies the connection simply as 'internal hex'. The 2020 summary is more specific. Both kept; the more specific and more recent record is shown first. Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Connection angle	Not verified
Anti-rotation index	Not verified
Prosthetic platforms	3.0, NP, RP, WP Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015) Conical connection implants & prosthetics — Product overview (86168 B GB 1906) (2019)

Size range

DiametersHow thick the implant is. Your dentist chooses based on your bone.	Ø3.0, 3.5, 4.3, 5.0, 5.5 mm Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015) Conical connection implants & prosthetics — Product overview (86168 B GB 1906) (2019)
LengthsHow long the implant is. Shorter ones are used where there is less bone.	7, 8.5, 10, 11.5, 13, 15, 18 mm (nominal) Nobel's product overview notes the actual TiUltra implant length is 0.5 mm shorter than the nominal length. Availability per diameter varies and is not yet mapped here. Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015) Conical connection implants & prosthetics — Product overview (86168 B GB 1906) (2019)

DiametersHow thick the implant is. Your dentist chooses based on your bone.

Ø3.0, 3.5, 4.3, 5.0, 5.5 mm

Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026

LengthsHow long the implant is. Shorter ones are used where there is less bone.

7, 8.5, 10, 11.5, 13, 15, 18 mm (nominal)

Nobel's product overview notes the actual TiUltra implant length is 0.5 mm shorter than the nominal length. Availability per diameter varies and is not yet mapped here.

Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026

Macrogeometry · technical detail for dentists

Thread design	Double-lead thread with reverse cutting flutes Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Apex	Drilling blades on apex Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Neck / collar	Not verified

Indications

Immediate function (labeling)Whether a temporary tooth may be fitted on the same day, according to official labeling. What the regulatory labeling permits. It is not evidence that immediate loading works better with this system.	US labeling: single or multiple units; immediate, early or delayed loading when sufficient primary stability and appropriate occlusal loading are achieved Regulatory record1 source · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015)
Restrictions & cautions	Ø3.0 implants: single-unit only; maxillary lateral incisor or mandibular central/lateral incisor Regulatory record2 sources · verified 27 Sept 2026 FDA 510(k) K142260 — NobelActive (510(k) summary) (2015) FDA 510(k) K202344 — TiUltra Implants and Xeal Abutments (510(k) summary) (2020)

Surgical protocol · technical detail for dentists

Max insertion torque	Not verified — in research queue

Regulatory records

Record	Device name (as filed)	Applicant	Decision	Date
K071370	NobelActive Internal Connection Implant	Nobel Biocare AB	Substantially Equivalent	3 Aug 2007
K083205	NobelActive 8.5 mm & 18.0 mm	Nobel Biocare AB	Substantially Equivalent	13 Feb 2009
K133731	NobelActive Wide Platform (WP)	Nobel Biocare AB	Substantially Equivalent	8 May 2014
K142260	NobelActive	Nobel Biocare AB	Substantially Equivalent	11 May 2015
K202344	TiUltra Implants and Xeal Abutments	Nobel Biocare AB	Substantially Equivalent	16 Nov 2020

FDA clearance means the FDA found the device substantially equivalent to a legally marketed device. It is not a ranking of quality or clinical results. EU (EUDAMED) records will be added.

Safety notices & recalls

Z-2207-2020 · Terminated · initiated 19 Jul 2019

NobelActive Internal NP 3.5x15mm, REF 34128: Top label could state 11.5 mm length for an implant that is actually 15 mm long. Root cause (FDA): Labeling mix-ups.

Concerns a labeling error on one reference (TiUnite-era internal NP 3.5×15 mm). It is not a finding about the NobelActive design as a whole.

openFDA recall search “product_description:NobelActive” run on 27 Sept 2026: 1 result(s). No result is not proof that no recall or field safety notice exists in any market.

Clinical evidence

We have not yet linked any system-specific studies to NobelActive. Evidence on materials, connections and loading protocols that applies across systems is in the evidence explorer. We don't quote single-study survival rates as brand scores.

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Sources

FDA 510(k) K142260 — NobelActive (510(k) summary) — U.S. Food and Drug Administration, 2015-05-11. Accessed 27 Sept 2026.
FDA 510(k) K202344 — TiUltra Implants and Xeal Abutments (510(k) summary) — U.S. Food and Drug Administration, 2020-11-16. Accessed 27 Sept 2026.
Conical connection implants & prosthetics — Product overview (86168 B GB 1906) — Nobel Biocare Services AG, 2019-06-01. Accessed 27 Sept 2026.
openFDA Device 510(k) API — U.S. Food and Drug Administration. Accessed 27 Sept 2026.

Nobel Biocare, NobelActive, TiUltra, TiUnite, Xeal and N1 are trademarks of Nobel Biocare Services AG. This site is not affiliated with, sponsored or endorsed by Nobel Biocare. Found an error? Email info@dentalimplantbrands.com.

Educational information only. Implant-system selection requires assessment by a qualified dental professional.