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Access Crown

FDA UDI

Class II (US FDA UDI)

by Centrix, Inc.

Identity

Trade Name
Access Crown FDA UDI
Generic Name
Temporary dental crown/bridge resin FDA UDI
Device Name
Access Crown BL temporary crown and bridge material, 50ml cartridge FDA UDI
Model / Reference
360038 FDA UDI
Description
Access Crown BL temporary crown and bridge material, 50ml cartridge FDA UDI

Identifiers

Primary DI / UDI-DI
00817051021201 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Temporary dental crown/bridge resin

Access Crown by Centrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge resin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centrix, Inc.

Sources (1)

  • FDA UDI 9a18b138-3c09-410b-bf61-346b7a8fc685 33 fields · synced Jun 6, 2026