510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070866Substantially Equivalent

Asc-12 Piezoelectric Scaler

Aseptico, Inc., Woodinville WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070866 is the FDA 510(k) clearance record for ASC-12 PIEZOELECTRIC SCALER, a class II device, cleared for Aseptico, Inc. on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 18 510(k) clearances for Aseptico, Inc., from to . As of , FDA records show no recalls naming K070866.

Clearance record

Decision date
Received
(13 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Aseptico, Inc. 8333 216th St. SE, Woodinville WA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260