Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- Rapid Holding Screw -3 FDA UDI
- Model / Reference
- 960-111-020-3 FDA UDI
- Description
- Rapid Holding Screw -3 FDA UDI
Identifiers
- Catalog Number
- 960-111-020-3 FDA UDI
- Primary DI / UDI-DI
- D82596011102030 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant/prosthesis surgical procedure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDILength — 5 Millimeter FDA UDI
Category: Dental implant/prosthesis surgical procedure kit
Quantum by Quantum Bioengineering, Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Quantum Bioengineering, Ltd.
Sources (1)
- FDA UDI 7789f367-4ad6-47a9-91ae-9079224217ee 36 fields · synced May 30, 2026