← Back to catalogue

Burkhart Dental Supply

FDA UDI

Class I (US FDA UDI)

by Burkhart Dental Supply Co., The

Identity

Trade Name
Burkhart Dental Supply FDA UDI
Generic Name
Dental wedge, single-use FDA UDI
Device Name
Matrix System Refill Small Wedges Yellow (100) FDA UDI
Model / Reference
72720968 FDA UDI
Description
Matrix System Refill Small Wedges Yellow (100) FDA UDI

Identifiers

Primary DI / UDI-DI
00815878025532 FDA UDI
FDA Product Code
JEP FDA UDI
GMDN Term
Dental wedge, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental wedge, single-use

Burkhart Dental Supply by Burkhart Dental Supply Co., The — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental wedge, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA UDI a4a38372-dc6f-4457-9db4-2e27df6a1f72 34 fields · synced Jun 8, 2026