PULPDENT DESENSITIZER

K963652 · Pulpdent Corp. · EBF · Oct 11, 1996 · Dental

Device Facts

• Record ID: K963652
• Device Name: PULPDENT DESENSITIZER
• Applicant: Pulpdent Corp.
• Product Code: EBF · Dental
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pulpdent DESENSITIZER is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.

Device Story

Pulpdent Desensitizer; aqueous mixture of hydroxyethylmethacrylate and glutaraldehyde. Applied by dental professionals to prepared cavities, dentin, and enamel; smear layer presence optional. Mechanism: bonds with dentinal tubule proteins to create physiologic barrier; controls dentinal fluid flow. Used in clinical dental settings to mitigate postoperative/microleakage sensitivity and treat cervical/root sensitivity. Output: chemical barrier formation; aids clinical decision-making by reducing patient discomfort during/after restorative procedures.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by literature review citing NIH Technology Assessment Conference on dental restorative materials, noting high benefit-to-risk ratio and lack of evidence for short or long-term risk over 20 years of general usage.

Technological Characteristics

Chemical composition: hydroxyethylmethacrylate and glutaraldehyde in water. Mechanism: protein bonding in dentinal tubules to form physiologic barrier. Form factor: liquid topical application.

Indications for Use

Indicated for patients requiring treatment for postoperative sensitivity, microleakage sensitivity, or cervical/root sensitivity during dental procedures including veneers, inlays, crowns, onlays, amalgams, and composite resins.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• American Dental Products Wetting Agent and Desensitizer
• Health-Dent Hema-Glu
• Miles Inc. Gluma

Submission Summary (Full Text)

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X963652

OCT 11 1996

# EXHIBIT 7

## 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 Desensitizer

**PREDICATE DEVICES:** American Dental Products *Wetting Agent and Desensitizer*
Health-Dent *Hema-Glu*
Miles Inc. *Gluma*

**DESCRIPTION AND INTENDED USE:** *Pulpdent DESENSITIZER* is a dental desensitizer used to control postoperative and microleakage sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. *Pulpdent DESENSITIZER* is a mixture of hydroxyethylmethacrylate and glutaraldehyde in water, which can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. *Pulpdent DESENSITIZER* controls dentinal fluid flow by bonding with the proteins in the tubules and thereby producing a physiologic barrier.

**COMPARISON WITH PREDICATE PRODUCTS:** *Pulpdent DESENSITIZER* is substantially equivalent in composition and intended use as the 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... composites... 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 journal articles.