SoftWedge™

FDA UDI

Class I (US FDA UDI)

by Garrison Dental Solutions, L.l.c.

Identity

Trade Name: SoftWedge™ FDA UDI
Generic Name: Dental wedge, single-use FDA UDI
Device Name: Wedge Refill, Medium, Orange FDA UDI
Model / Reference: WSDOR FDA UDI
Description: Wedge Refill, Medium, Orange FDA UDI

Identifiers

Catalog Number: WSDOR FDA UDI
Primary DI / UDI-DI: 10810038093403 FDA UDI
FDA Product Code: DZN 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental wedge, single-use

SoftWedge™ by Garrison Dental Solutions, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental wedge, single-use.

Henry Schein — HENRY SCHEIN, INC. · Class I
Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
Bioclear Diamond Wedge — Bioclear Matrix Systems, LLC · Class I
Wykle Wedges 17mm Green Color 500 count — WYKLE RESEARCH, INC. · Class I
Uni-Wedge Regular Orange (250) — Hager Worldwide, Inc. · Class I
PRO-ELAST — Ortho Pro Dent LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Garrison Dental Solutions, L.l.c.

Sources (1)

FDA UDI 98e9a47b-ecf8-4d67-af01-c716bc260be8 35 fields · synced May 31, 2026