Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Healing Cap 3.5 3R FDA UDI
- Model / Reference
- 060-135-100-3 FDA UDI
- Description
- Healing Cap 3.5 3R FDA UDI
Identifiers
- Catalog Number
- 060-135-100-3 FDA UDI
- Primary DI / UDI-DI
- D82506013510030 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable 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
Yes
FDA UDI
Implantable
Yes
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
No
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
- Length — 3.5 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, reusable
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 61629b52-bf15-4b63-a525-97585da59d62 36 fields · synced Jun 8, 2026