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Implantswiss Dental Implant Prosthetic Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref S-BTPK
by Novodent Sa
Identity
- Trade Name
- Implantswiss Dental Implant Prosthetic Kit EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Implantswiss Dental Implant Prosthetic Kit EUDAMEDDental Implant Prosthetic Kit Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
- Model / Reference
- S-BTPK EUDAMEDFDA UDI
- Description
- Dental Implant Prosthetic Kit Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses. FDA UDI
Identifiers
- Catalog Number
- S-BTPK FDA UDI
- Primary DI / UDI-DI
- 07640168184551 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016818BTPKGA EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Medical Purpose
- A dental implant surgical kit is specifically designed for the placement of dental implants, which are used to replace missing teeth. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Implantswiss Dental Implant Prosthetic Kit by Novodent SA — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016818BTPKGA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Novodent Sa
- EUDAMED SRN
- CH-PR-000042189
Sources (2)
- EUDAMED a7776440-5808-4a46-8e7c-6f409f4ce317 61 fields · synced Jun 18, 2026
- FDA UDI e0912a97-6bdf-4014-89ae-fa0988dad530 34 fields · synced May 30, 2026