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Healing Cap Multi-unit Titanium Ø5.0x4.1mm 2/pkg

by Nobel Biocare AB EUDAMED510(k)GUDID

Active United States and European Union

Ref 300162

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73327470000001236T Basic UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747192162 UDI-DIDate29 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK171142 Date26 Oct 2017IssuedStatusActive

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Healing Cap Multi-unit Titanium Ø5.0x4.1mm 2/pkg EUDAMED
Multi-unit Abutment GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Healing abutments
Model / Ref / Catalog
300162
Primary DI / UDI-DI
07332747192162
Basic UDI-DI
73327470000001236T
Unit of Use DI
07332747156454
FDA Product Code
NHA
EMDN Code
P01020180 Dental implants - accessories
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 5.000 Millimeter
Height — 4.100 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000000009

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Premarket Exempt: No
  • Serial Number: No