Salvin Dental Specialties

FDA UDI

Class U (US FDA UDI)

by Salvin Dental Specialties, Llc

Identity

Trade Name: Salvin Dental Specialties FDA UDI
Generic Name: General oral wound dressing, animal-derived FDA UDI
Device Name: Salvin OraTAPE® Plus Resorbable Collagen Wound Dressing - Package of 10 FDA UDI
Model / Reference: ORATAPE-PLUS-PKG-10 FDA UDI
Description: Salvin OraTAPE® Plus Resorbable Collagen Wound Dressing - Package of 10 FDA UDI

Identifiers

Catalog Number: ORATAPE-PLUS-PKG-10 FDA UDI
Primary DI / UDI-DI: 00841336128798 FDA UDI
510(k) Number: K152600 FDA UDI
FDA Product Code: KGN FDA UDI
GMDN Term: General oral wound dressing, animal-derived FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 25 Millimeter FDA UDI
Length — 75 Millimeter FDA UDI

Category: General oral wound dressing, animal-derived

Salvin Dental Specialties by Salvin Dental Specialties, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General oral wound dressing, animal-derived.

OUSIA bioPLUG — ACE SURGICAL SUPPLY CO., INC. · Class II
HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
RCF Resorbable Collagen Foam — ACE SURGICAL SUPPLY CO., INC. · Class II
Symbios® Collagen Tape — Dentsply Implants Manufacturing GmbH · U
creos™ — Integra Lifesciences Corp. · Class III
CollaPlug® — Integra Lifesciences Corp. · Class III
RCT Resorbable Collagen Tape — ACE SURGICAL SUPPLY CO., INC. · Class II
GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U

Cleared under the same submission

K152600 also covers:

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 U	Pending data

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Manufacturer

Manufacturer: Salvin Dental Specialties, Llc

Sources (1)

FDA UDI 7c1f2cdc-8639-4391-8ffb-2349ff02c424 38 fields · synced May 31, 2026