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Guided Dense Bone Screw Tap NobelActive® RP 5.0 8.5-18 mm

by Nobel Biocare AB

Ref 38181

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083205↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number733274700000014473 Basic UDI-DI 07332747191554UDI-DIDate5 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747191554 UDI-DI Date29 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK083205 Date13 Feb 2009IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Guided Dense Bone Screw Tap NobelActive® RP 5.0 8.5-18 mm EUDAMED
NobelActive® GUDID
Generic Name
Bone tap, single-use
Device Name
Guided drills for osteotomy
Model / Ref / Catalog
38181
Primary DI / UDI-DI
07332747191554
Basic UDI-DI
733274700000014473
FDA Product Code
NDP
EMDN Code
Q010501 Dental burs and abrasive disks, single-use
GMDN Term
Bone tap, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5.000 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
SE-MF-000000009

Related devices

Category: Carbide dental bur, single-use

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No