
A-Dec, Inc.
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A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 is an FDA 510(k)-cleared medical device (K082716) manufactured by A-Dec, Inc.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 14, 2009. Regulation: 8.