No-Stick Composite Instrument Dip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K901050 FDA 510(k)
- FDA Product Code
- EBD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3310 FDA 510(k)
- Regulation Number
- 872.3310 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The No-Stick Composite Instrument Dip is a Coating, Filling Material, Resin designed to prevent restorative composites from adhering to dental placement instruments. It functions as a light-cured, unfilled resin solution applied to instruments to facilitate smooth composite handling during dental restorative procedures.
This single-use dental accessory is supplied as a liquid solution and is intended for use in clinical settings. It is classified as a Class II device under FDA regulations (872.3310) and was granted FDA 510(k) clearance (K901050) in 1990. No sterility or MRI safety information is specified, and it is not intended for reusable applications.
Frequently asked questions
What is the No-Stick Composite Instrument Dip used for in dental procedures?
The No-Stick Composite Instrument Dip is a light-cured, unfilled resin solution designed specifically to prevent restorative dental composites from sticking to placement instruments. It makes handling composites smoother during restorative procedures by creating a non-adherent surface on the tools.
Is the No-Stick Composite Instrument Dip intended for reusable instruments, or is it meant for single-use?
The No-Stick Composite Instrument Dip is explicitly labeled as a single-use dental accessory. It is formulated as a liquid solution applied to instruments during a procedure, not for repeated applications or reuse.
How is the No-Stick Composite Instrument Dip supplied, and what form does it take?
The product is supplied as a liquid solution, packaged for clinical use. It is a coating designed to be applied to dental instruments before handling composites, ensuring they remain free of residue during restorative work.
Does the No-Stick Composite Instrument Dip require any special storage conditions?
The provided data does not specify any special storage requirements for the No-Stick Composite Instrument Dip. However, as with most dental liquids, it should be stored in a cool, dry place away from direct sunlight and protected from contamination until use.
What regulatory pathway was followed for FDA clearance of the No-Stick Composite Instrument Dip?
The No-Stick Composite Instrument Dip received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device (product code EBD) with a decision of 'Substantially Equivalent' by the Dental Devices Advisory Committee. The clearance was granted in 1990 under registration number K901050.
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: NO-STICK COMPOSITE INSTRUMENT DIP (K901050) — FDA 510(k) | Innolitics, PDF K901050 - No-stick Composite Instrument Dip, No Stick Composite Accessories Dental Supplies, 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 | K901050 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K901050 24 fields · synced Sep 18, 2026