← Back to catalogue
NobelPearl™ Tapered Surgery Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 301267Model Surgery Tray, fully equipped
Identity
- Trade Name
- NobelPearl™ Tapered Surgery Kit EUDAMEDFDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- NobelPearl surgery & prosthetic kit FDA UDI
- Model / Reference
- Surgery Tray, fully equipped EUDAMED301267 EUDAMEDFDA UDI
- Description
- NobelPearl surgery & prosthetic kit FDA UDI
Identifiers
- Catalog Number
- 301267 FDA UDI
- Primary DI / UDI-DI
- 07640161397231 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT48854KL22SKMN EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- 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
No
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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
NobelPearl™ Tapered Surgery Kit by CeramTec Schweiz GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016139XT48854KL22SKMN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-PR-000042804
Sources (2)
- EUDAMED 3a026fff-6348-4f75-9fb8-fbd0f00db21d 61 fields · synced Jun 8, 2026
- FDA UDI 1af07b8d-0733-4928-af35-30b871dfd55b 36 fields · synced May 30, 2026