510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K112188Substantially Equivalent

Piezotome Solo

Satelec - Acteon, Inc., Mt. Laurel NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112188 is the FDA 510(k) clearance record for PIEZOTOME SOLO, a class II device, cleared for Satelec - Acteon, Inc. on under FDA product code DZI (Drill, Bone, Powered). FDA records list one 510(k) clearance for Satelec - Acteon, Inc. As of , FDA records show no recalls naming K112188.

Clearance record

Decision date
Received
(189 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Satelec - Acteon, Inc. 124 Gaither Dr. Suite #140, Mt. Laurel NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260