Dentastic Unfilled Resin Bonding Agent

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: DENTASTIC UNFILLED RESIN BONDING AGENT FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: 6 mL Part 1 only - Base - light activated FDA UDI
Model / Reference: DASP1 FDA UDI
Description: 6 mL Part 1 only - Base - light activated FDA UDI

Identifiers

Primary DI / UDI-DI: D701DASP12 FDA UDI
FDA Product Code: KLE FDA UDI
GMDN Term: Dentine adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 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

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: Dentine adhesive

Dentastic Unfilled Resin Bonding Agent by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine adhesive.

SEPTODONT HZ IMAGE MH COMP L/C SYR KIT — Septodont · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Peak Universal Bond — ULTRADENT PRODUCTS, INC. · Class II
E-ON — BENCO DENTAL SUPPLY CO. · Class II
PermaFlo DC — ULTRADENT PRODUCTS, INC. · Class II
Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, 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 9244e78c-c827-467b-a3b9-07f978d5dfc5 33 fields · synced Jun 9, 2026