Identity
- Trade Name
- COUPLE IMPRESSION TRANSFER SCREW FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
- Model / Reference
- ACITSM-S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020806178 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
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
Yes
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 prosthesis/implant abutment screw analog, single-use
Couple Impression Transfer Screw by SNUCONE Co., LTD. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw analog, single-use.
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- Preat — PREAT Corporation · Class I
- Transfer Impression Coping Guide Pin — Izenimplant Co., Ltd. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
- Pick-up Impression Coping — Izenimplant Co., Ltd. · Class I
- Paltop — Paltop Advanced Dental Solutions, 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
- SNUCONE Co., LTD.
Sources (1)
- FDA UDI 47e04f5f-e720-4ad6-a0ce-b42e6ff9ed3e 33 fields · synced Jun 1, 2026