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Yamahachi Pmma Disk

FDA UDI

Class II (US FDA UDI)

by Yamahachi Dental Mfg., Co.

Identity

Trade Name
YAMAHACHI PMMA DISK FDA UDI
Generic Name
Temporary dental crown/bridge resin FDA UDI
Model / Reference
95mm*20mm, B3 FDA UDI

Identifiers

Primary DI / UDI-DI
04582275719642 FDA UDI
510(k) Number
K151764 FDA UDI
FDA Product Code
EBG FDA UDI
GMDN Term
Temporary dental crown/bridge resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Yamahachi Pmma Disk by Yamahachi Dental Mfg., Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151764 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Yamahachi Dental Mfg., Co.

Sources (1)

  • FDA UDI 6473b4c9-847a-4cdf-b820-e0bb67c69889 33 fields · synced Oct 6, 2026