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NobelPearl™ Abutment Screw Retrieval Kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 301307Model Rescue-Set

by CeramTec Schweiz GmbH

Identity

Trade Name
NobelPearl™ Abutment Screw Retrieval Kit EUDAMEDFDA UDI
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Model / Reference
Rescue-Set EUDAMED
301307 EUDAMEDFDA UDI

Identifiers

Catalog Number
301307 FDA UDI
Primary DI / UDI-DI
07640161397309 EUDAMEDFDA UDI
Basic UDI-DI
764016139R98000KL22RKNE EUDAMED
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Medical Purpose
The kits are intended to enable the placing and/or restoration of dental implants EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

NobelPearl™ Abutment Screw Retrieval Kit by CeramTec Schweiz GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CeramTec Schweiz GmbH
EUDAMED SRN
CH-PR-000042804

Sources (2)

  • EUDAMED a6539820-007d-4aef-9d8c-4b06ae5a6341 61 fields · synced Jul 13, 2026
  • FDA UDI 05b3fe50-7920-400a-ba4a-9bd760da5115 35 fields · synced May 30, 2026