Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000112 ↗

FDA Product Code

EIA

Models / Variants

A1222B

A1223B

A1221B

A1121B

A1222C

A10402

A10403

A10401

Device Class

Class I

Regulation

21 CFR Part 872.6640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Disposable Screw Type Prophy Brush

  Class I

  FDA 510(k) K900507 Active Cleared 10 Apr 1990

• Sterile Flexofile Files and Instruments

  Class I

  FDA 510(k) K971606 Active Cleared 3 Jun 1997

• Delton F Pit & Fissure Sealant

  Class II

  FDA 510(k) K951296 Active Cleared 3 May 1995

• Fluoride Varnish

  Class II

  FDA 510(k) K031932 Active Cleared 15 Sep 2003

• Dentsply Cavitron Sps Scaler System

  Class II

  FDA 510(k) K970123 Active Cleared 11 Apr 1997

• Delton Fs Direct Delivery System

  Class II

  FDA 510(k) K982564 Active Cleared 6 Oct 1998

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