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Impression Coping

FDA UDI

Class I (US FDA UDI)

by Megagen Implant Co. Ltd

Identity

Trade Name
Impression Coping FDA UDI
Generic Name
Dental precision attachment simulator/analog, single-use FDA UDI
Device Name
BLUEDIAMOND Implant System Ø5/ C=3/ L=12/ Transfer/ NC FDA UDI
Model / Reference
BDICTN5012 FDA UDI
Description
BLUEDIAMOND Implant System Ø5/ C=3/ L=12/ Transfer/ NC FDA UDI

Identifiers

Catalog Number
BDICTN5012T FDA UDI
Primary DI / UDI-DI
08809822760657 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
Sterilization Method
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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Megagen Implant Co. Ltd

Sources (1)

  • FDA UDI e11f40fa-b108-4a46-961e-a2a4c0b8c72f 34 fields · synced May 30, 2026