Seal-Rite™ Low Viscosity

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: Seal-Rite™ Low Viscosity FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: KIT: 4 x 1.2 mL syringes + 8 applicator tips, off-white 7.7% Filled FDA UDI
Model / Reference: SEALLV FDA UDI
Description: KIT: 4 x 1.2 mL syringes + 8 applicator tips, off-white 7.7% Filled FDA UDI

Identifiers

Primary DI / UDI-DI: D701SEALLV2 FDA UDI
FDA Product Code: EBC FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 pit/fissure sealant

Seal-Rite™ Low Viscosity by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Pulpdent Corporation

Sources (1)

FDA UDI 6069e587-0da2-4763-8fb4-21c4e9dbc617 33 fields · synced Jun 9, 2026