Pulpdent Enamel Bonding Agent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K911282 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Enamel Bonding Agent is a dental adhesive classified as an Agent, Tooth Bonding, Resin, designed to bond dental restorative materials to enamel. It facilitates durable adhesion between composite resins and tooth surfaces, ensuring structural integrity in restorative procedures.
This agent is supplied as a single-use product and is intended for use in dental settings. It is classified under FDA regulation number 872.3200 and received FDA 510K clearance under the Traditional pathway, with a decision date of 1991-09-06. The product is non-sterile and must be handled according to standard dental practice guidelines.
Frequently asked questions
What is the primary purpose of the Pulpdent Enamel Bonding Agent in dental procedures?
The Pulpdent Enamel Bonding Agent is designed to bond dental restorative materials—such as composite resins—to the enamel of teeth. Its role is to create a durable and strong adhesive interface, ensuring the restored area maintains structural integrity during chewing and other oral functions.
Is the Pulpdent Enamel Bonding Agent intended for single-use only, and how should it be handled?
Yes, the Pulpdent Enamel Bonding Agent is explicitly supplied as a single-use product. Since it is non-sterile, it must be handled according to standard dental practice guidelines, including proper sterilization of instruments and adherence to infection control protocols during use.
What regulatory pathway was followed for FDA clearance of this bonding agent, and when was the decision made?
The Pulpdent Enamel Bonding Agent received FDA clearance through the Traditional 510(k) pathway, with a decision date of September 6, 1991. The clearance was granted under the classification of 'Substantially Equivalent' (SESE) and falls under FDA regulation number 872.3200 for dental adhesives.
Are there multiple sizes or models of the Pulpdent Enamel Bonding Agent, or is it available in a single formulation?
The provided data lists multiple FEI (Final Establishment Identification) numbers, which typically correspond to different manufacturing lots or batch identifiers rather than distinct sizes or models. This suggests the product is available in a single formulation but may be produced in various batches for distribution.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DenTASTIC™ UNO™ - PULPDENT, Pulpdent Corp | Bonding Agents | Dental Supplies | TDSC.com, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K911282 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K911282 24 fields · synced Sep 18, 2026