Ribbon

FDA UDI

Class II (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Ribbon FDA UDI
Generic Name: Dental unfilled resin sealant/coating FDA UDI
Device Name: TSP Ribbon Mix Syringe Refill FDA UDI
Model / Reference: RIBFILL FDA UDI
Description: TSP Ribbon Mix Syringe Refill FDA UDI

Identifiers

Catalog Number: RIBFILL FDA UDI
Primary DI / UDI-DI: D716RIBFILL1 FDA UDI
FDA Product Code: KIF FDA UDI
GMDN Term: Dental unfilled resin sealant/coating FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3820 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 6 Milliliter FDA UDI

Category: Dental unfilled resin sealant/coating

Ribbon by Tulsa Dental Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental unfilled resin sealant/coating.

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UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
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UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
Champ — CENTRIX, INC. · Class II
OptiGuard — KERR CORPORATION · Class II
OPTIGLAZE™ — Gc America Inc. · Class II
RE-GEN Pit & Fissure Sealant — Vista Dental · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Tulsa Dental Products Llc

Sources (1)

FDA UDI 7ec10cad-3613-43d4-bbcb-15099f69fd01 37 fields · synced Jun 8, 2026