Identity
- Trade Name
- PMMA Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- BDPAN0608DT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809854026028 FDA UDI
- 510(k) Number
- K234142 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
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
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
PMMA Abutment by Megagen Implant 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
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Cleared under the same submission
K234142 also covers:
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant Co. Ltd
- PMMA Abutment — Megagen Implant 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
- Megagen Implant Co. Ltd
Sources (1)
- FDA UDI 38f906b6-63c2-4262-ab17-5dfae45d94ab 33 fields · synced Jun 8, 2026