Identity
- Trade Name
- Impression Coping FDA UDI
- Generic Name
- Dental precision attachment simulator/analog, single-use FDA UDI
- Device Name
- ST Internal Implant System Impression Coping Ø4/ L=15/ Pick-up/ Mini FDA UDI
- Model / Reference
- STPIM4015 FDA UDI
- Description
- ST Internal Implant System Impression Coping Ø4/ L=15/ Pick-up/ Mini FDA UDI
Identifiers
- Catalog Number
- STPIM4015T FDA UDI
- Primary DI / UDI-DI
- 08806388250868 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental precision attachment simulator/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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental precision attachment simulator/analog, single-use
Impression Coping by Megagen Implant Co. Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental precision attachment simulator/analog, single-use.
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- Transfer Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Pick-Up Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Transfer Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Transfer Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Pick-Up Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Pick-Up Impression Coping — POINTIMPLANT Co., Ltd. · Class I
- Transfer Impression Coping — POINTIMPLANT Co., 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
- Megagen Implant Co. Ltd
Sources (1)
- FDA UDI 33ed7037-9c6c-4642-a288-6ac7c4c55727 34 fields · synced May 30, 2026