Ortho-Coat™, Ortho-Choice

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: ORTHO-COAT™, ORTHO-CHOICE FDA UDI
Generic Name: Dental unfilled resin sealant/coating FDA UDI
Device Name: 2 x 5 mL syringes Ortho-Coat, + 20 applicator tips FDA UDI
Model / Reference: OC FDA UDI
Description: 2 x 5 mL syringes Ortho-Coat, + 20 applicator tips FDA UDI

Identifiers

Primary DI / UDI-DI: D701OC2 FDA UDI
510(k) Number: K052281 FDA UDI
FDA Product Code: EBD FDA UDI
EBC FDA UDI
GMDN Term: Dental unfilled resin sealant/coating FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3310 FDA UDI
872.3765 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Dental unfilled resin sealant/coating

Ortho-Coat™, Ortho-Choice by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental unfilled resin sealant/coating.

UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
ResinBlend LV Composite Blending Resin — Den-Mat Holdings, LLC · Class II
Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
Champ — CENTRIX, INC. · Class II
OptiGuard — KERR CORPORATION · Class II
OPTIGLAZE™ — Gc America Inc. · 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

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

Manufacturer

Manufacturer: Pulpdent Corporation

Sources (1)

FDA UDI f9ccca15-e6d3-4707-9c45-ef44c7080248 34 fields · synced Jun 9, 2026