PULPDENT SEAL-RITE UDMA

K963921 · Pulpdent Corp. · EBC · Nov 12, 1996 · Dental

Device Facts

• Record ID: K963921
• Device Name: PULPDENT SEAL-RITE UDMA
• Applicant: Pulpdent Corp.
• Product Code: EBC · Dental
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent Seal-Rite™UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth.

Device Story

Radiopaque, fluoride-releasing, visible light-cure dental sealant; UDMA-based; Bisphenol A-free. Medium consistency paste; flows cusp-to-cusp; visible contrast against enamel. Applied by dental clinicians in clinical settings; cured via visible light for 20 seconds. Used to prevent dental caries by sealing pits and fissures. Benefits include caries prevention and fluoride release.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by reference to NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, citing high benefit-to-risk ratio and long-term usage history of similar dental restorative materials.

Technological Characteristics

UDMA-based dental sealant; radiopaque; fluoride-releasing; visible light-cure. Complies with ANSI/ADA Specification No. 39. Bisphenol A-free formulation.

Indications for Use

Indicated for sealing pits and fissures of teeth in patients requiring dental sealant treatment.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• Pulpdent Seal-Rite
• Seal-Rite Low Viscosity
• Vivodent/Ivoclar Helioseal
• HelioSeal-F
• Kulzer Estiseal
• Ultradent Ultra-Blend

Submission Summary (Full Text)

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NOV 12 1996
K963921
14

# EXHIBIT 8

## RESPONSE TO SMDA OF 1990

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

| Kenneth J. Berk
80 Oakland Street
PO Box 780
Watertown, MA 02272-0780
USA | TELEPHONE: [phone]
FAX: [phone] |
| --- | --- |

**DEVICE NAME:** Pulpdent Seal-Rite™ UDMA

**PREDICATE DEVICE:** Pulpdent Seal-Rite and Seal-Rite Low Viscosity<br/>Vivodent/Ivoclar Helioseal and HelioSeal-F<br/>Kulzer Estiseal<br/>Ultradent Ultra-Blend

**DESCRIPTION AND INTENDED USE:** Pulpdent Seal-Rite™UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth. It contains no Bisphenol A. It is supplied as a medium consistency paste, which flows readily from cusp to cusp and is easily distinguishable from enamel. Pulpdent Seal-Rite™UDMA cures completely after light curing for 20 seconds. Various formulations (with and without color, with and without fluoride) will be offered to allow for the clinician's discretion and preference in different situations. Pulpdent Seal-Rite™UDMA complies with ANSI/ADA Specification No. 39 for Pit and Fissure Sealants.

**COMPARISON WITH PREDICATE PRODUCTS:** Pulpdent Seal-Rite™UDMA is substantially equivalent in composition and/or intended use to the above mentioned predicate products. Please see EXHIBIT 5 for the entire comparison.

**SAFETY AND EFFECTIVENESS:** According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble free. There is no evidence of short or long term risk...there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.