← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K963652 # PULPDENT DESENSITIZER (K963652) _Pulpdent Corp. · EBF · Oct 11, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K963652 ## Device Facts - **Applicant:** Pulpdent Corp. - **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md) - **Decision Date:** Oct 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3690 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (617) 926-6666 FAX: (617) 926-6262 **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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K963652](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K963652) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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