Identity
- Trade Name
- KONTACT FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Implant analog FDA UDI
- Model / Reference
- KDI FDA UDI
- Description
- Implant analog FDA UDI
Identifiers
- Catalog Number
- KDI FDA UDI
- Primary DI / UDI-DI
- 03701045231264 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant analog
Kontact by Biotech Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant analog.
- Digital Lab Analog Screw — DENTIS CO. , LTD · Class I
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM — DIO Corporation · Class I
- One Stage TL S — I3 IMPLANT LLC · Class II
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biotech Dental
Sources (1)
- FDA UDI 2fdf99fa-6f0a-4823-a9e4-adf78f9d69aa 35 fields · synced May 31, 2026