Identity
- Trade Name
- Bite Impression Coping FDA UDI
- Generic Name
- Dental precision attachment simulator/analog, single-use FDA UDI
- Model / Reference
- OBICM4003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011266622 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental precision attachment simulator/analog, single-use
Bite Impression Coping by POINTIMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Impression Coping — Megagen Implant Co. Ltd · Class I
- Impression Coping — Megagen Implant 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
- POINTIMPLANT Co., Ltd.
Sources (1)
- FDA UDI 547a096f-4e2e-47e0-8f42-39f6faabaa8d 32 fields · synced May 31, 2026