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ZrGEN Abutment

FDA UDI

Class II (US FDA UDI)

by Megagen Implant Co. Ltd

Identity

Trade Name
ZrGEN Abutment FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
BLUEDIAMOND Implant System Ø4.5/ C=0.6/ H=4.5/ RC FDA UDI
Model / Reference
AROZGR4515 FDA UDI
Description
BLUEDIAMOND Implant System Ø4.5/ C=0.6/ H=4.5/ RC FDA UDI

Identifiers

Catalog Number
AROZGR4515.MTN FDA UDI
Primary DI / UDI-DI
08806388267484 FDA UDI
510(k) Number
K220562 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
Not 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

ZrGEN Abutment by Megagen Implant Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K220562 also covers:

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 062c6190-1b52-4987-9bf1-d6d7cc97ad18 36 fields · synced Jun 1, 2026