← Back to catalogue

Hu-Friedy

FDA UDI

Class I (US FDA UDI)

by Hu-Friedy Mfg Co., Llc

Identity

Trade Name
HU-FRIEDY FDA UDI
Generic Name
Dental restoration carver, resin FDA UDI
Device Name
SB4/678-901H, #6 HANDLE FDA UDI
Model / Reference
PI7152 FDA UDI
Description
SB4/678-901H, #6 HANDLE FDA UDI

Identifiers

Catalog Number
PI7152 FDA UDI
Primary DI / UDI-DI
10889950083526 FDA UDI
FDA Product Code
GEJ FDA UDI
GMDN Term
Dental restoration carver, resin FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental restoration carver, resin

Hu-Friedy by Hu-Friedy Mfg Co., Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental restoration carver, resin.

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 ec31ff47-aba9-40f1-821e-157e36faafc0 35 fields · synced May 29, 2026