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Atlas Surgical and Prosthetic Instrumentation Kit
FDA UDIClass I (US FDA UDI)
by Dentatus AB
Identity
- Trade Name
- Atlas Surgical and Prosthetic Instrumentation Kit FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- ATLAS Surgical and Prosthetic Instrumentation kit - Drill System 2 3x CePo Drills - Short (=1.8 mm implants, 2.2, 2.4 ) - Drill System 2 1x R/A Hpc. Implant Driver 1x Manual R/A Adaptor 1x Set of 3 Denture Profile Forming Instruments 1x Sterilizable Instrumentation Kit Box 1x Instruction for use 1x X-ray template 5x Moisture Absorbing Papers FDA UDI
- Model / Reference
- AK-3 FDA UDI
- Description
- ATLAS Surgical and Prosthetic Instrumentation kit - Drill System 2 3x CePo Drills - Short (=1.8 mm implants, 2.2, 2.4 ) - Drill System 2 1x R/A Hpc. Implant Driver 1x Manual R/A Adaptor 1x Set of 3 Denture Profile Forming Instruments 1x Sterilizable Instrumentation Kit Box 1x Instruction for use 1x X-ray template 5x Moisture Absorbing Papers FDA UDI
Identifiers
- Catalog Number
- AK-3 FDA UDI
- Primary DI / UDI-DI
- 07350081494872 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure kit 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implant suprastructure kit
Atlas Surgical and Prosthetic Instrumentation Kit by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dentatus AB
Sources (1)
- FDA UDI b3fcb02c-cdeb-4010-a6ca-70ec5c97f33a 35 fields · synced May 30, 2026