Muliti-unit Angled Abutment

FDA UDI

Class II (US FDA UDI)

by Megagen Implant Co. Ltd

Identity

Trade Name: Muliti-unit Angled Abutment FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: BLUEDIAMOND FDA UDI
Model / Reference: MUABDNO1765 FDA UDI
Description: BLUEDIAMOND FDA UDI

Identifiers

Catalog Number: MUABDNO1765TC FDA UDI
Primary DI / UDI-DI: 08809931188007 FDA UDI
510(k) Number: K233450 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental implant suprastructure, permanent, preformed

A comprehensive medical device directory for the Muliti-unit Angled Abutment, a prefabricated dental implant suprastructure designed for permanent intermediate fixation between a dental implant and final prosthesis/restoration. The device features one or more structural components, made of various materials, including titanium (Ti), plastic, gold alloy, and can be reused during cleaning cycles.

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Temporary Abutment — Cybermed Inc. · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II

Cleared under the same submission

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

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Manufacturer

Manufacturer: Megagen Implant Co. Ltd

Sources (1)

FDA UDI b59df52d-639f-404a-9567-eb58285758f7 35 fields · synced Jul 24, 2026

Muliti-unit Angled Abutment

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)