Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Q Fit Analog FDA UDI
- Model / Reference
- 512-600-000 FDA UDI
- Description
- Q Fit Analog FDA UDI
Identifiers
- Catalog Number
- 512-600-000 FDA UDI
- Primary DI / UDI-DI
- D8255126000000 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant analog 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
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
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 — 5 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: Dental implant analog
Quantum by Quantum Bioengineering, Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Quantum Bioengineering, Ltd.
Sources (1)
- FDA UDI 14fa913f-5eb7-4f76-8de1-64e851ceca9d 36 fields · synced Jun 8, 2026