Identity
- Trade Name
- SNUCONE BONE LEVEL IMPLANT SYSTEM FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- ACAMR-45425-FA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020845771 FDA UDI
- 510(k) Number
- K210354 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Snucone Bone Level Implant System by SNUCONE Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K210354 also covers:
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SNUCONE Co., LTD.
Sources (1)
- FDA UDI c680659f-c5c8-4e30-9af9-538e5c97045c 34 fields · synced May 30, 2026