Identity
- Trade Name
- Prosthetic Accessories FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDAAnalog for P14 FDA UDI
- Model / Reference
- D1-P14 EUDAMEDFDA UDI
- Description
- AAnalog for P14 FDA UDI
Identifiers
- Catalog Number
- D1-P14 FDA UDI
- Primary DI / UDI-DI
- 07290107274241 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011127TOOLSClassI3T EUDAMED
- 510(k) Number
- K132125 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant analog
Prosthetic Accessories by A.b. Dental Devices Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant analog.
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- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
Cleared under the same submission
K132125 also covers:
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A.b. Dental Devices Ltd
Sources (2)
- FDA UDI 409e5e01-8996-48f2-a9de-fdc158f6ffc0 36 fields · synced Jun 18, 2026
- EUDAMED a3af82a5-b9de-4674-b366-ccf2a1ef1fde 61 fields · synced Jun 18, 2026