Identity
- Trade Name
- Implant Spacers FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Implant Spacers Set #2- for approximating space between teeth and/or implants - 4.5, 5.0, 6.0, 7.0, 8.0, & 9.0mm FDA UDI
- Model / Reference
- Implant Spacers Set#2 FDA UDI
- Description
- Implant Spacers Set #2- for approximating space between teeth and/or implants - 4.5, 5.0, 6.0, 7.0, 8.0, & 9.0mm FDA UDI
Identifiers
- Catalog Number
- Implant Spacers Set #2 FDA UDI
- Primary DI / UDI-DI
- 00083208190025 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 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
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
Category: Dental implantation depth/angle gauge, reusable
Implant Spacers by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Neoss Implant System — Neoss, Ltd. · 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
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI d3fbf6d3-6ffd-4e98-a98f-3925ba8788a3 35 fields · synced May 31, 2026