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Ultradent Composite Gun

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
Ultradent Composite Gun FDA UDI
Generic Name
Dental material application tool, reusable FDA UDI
Device Name
Ultradent Composite Gun FDA UDI
Model / Reference
7800 FDA UDI
Description
Ultradent Composite Gun FDA UDI

Identifiers

Catalog Number
7800 FDA UDI
Primary DI / UDI-DI
00883205033321 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Dental material application tool, reusable 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental material application tool, reusable

Ultradent Composite Gun by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material application tool, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI 2d74637e-cc4e-4a2a-b34b-e5afe87f4275 35 fields · synced May 30, 2026