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Air Block

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896662

by Pulpdent Corporation

Identifiers

510(k) Number
K896662 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Air Block is a dental device classified as a Dental Rubber Dam Clamp (Product Code EBF), designed to secure a rubber dam around a tooth during dental procedures. It provides isolation to maintain a dry working field, preventing contamination and improving visibility and access for restorative or endodontic treatments. Constructed for precision, it ensures stable positioning while minimizing patient discomfort.

The Air Block is supplied as a single-use device, intended for use in dental offices and clinics. It is not sterilized but is packaged in a sterile barrier for immediate clinical application. The device is non-magnetic and safe for use in non-MRI environments. Sizes are standardized for compatibility with common dental dam systems, and storage requires protection from moisture and extreme temperatures. Its regulatory status includes FDA 510(k) clearance under K896662, granted in 1990.

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: AIR BLOCK (K896662) — FDA 510(k) | Innolitics, PULPDENT ® Corporation - Advancing Dentistry Together, PDF Pulpdent Corporation Revision Date: August 1, 2024 EN - Safety Data Sheet, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ..., Pulpdent Corporation Products - dentalproductshopper.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K896662 24 fields · synced Sep 20, 2026