
Den-Tal-Ez Mfg Co., Inc.
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AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) is an FDA 510(k)-cleared medical device (K931204) manufactured by Den-Tal-Ez Mfg Co., Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 7, 1993. Regulation: 8.