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C&B MetaBond®

FDA UDI

Class II (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name
C&B MetaBond® FDA UDI
Generic Name
Dental material mixing surface, chairside, reusable FDA UDI
Device Name
Ceramic Mixing Dish for C&B MetaBond® FDA UDI
Model / Reference
S385 FDA UDI
Description
Ceramic Mixing Dish for C&B MetaBond® FDA UDI

Identifiers

Catalog Number
S387 FDA UDI
Primary DI / UDI-DI
00810000529186 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dental material mixing surface, chairside, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental material mixing surface, chairside, reusable

C&B MetaBond® by Parkell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material mixing surface, chairside, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA UDI 102d5a67-7f4f-4c82-b734-de3a8fecd123 35 fields · synced Jun 8, 2026