510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K132570Substantially Equivalent

Electric Handpiece System

Ttbio Corp., Taichung, Roc, TW / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132570 is the FDA 510(k) clearance record for ELECTRIC HANDPIECE SYSTEM, a class I device, cleared for Ttbio Corp. on under FDA product code EBW (Controller, Foot, Handpiece And Cord). FDA records list 2 510(k) clearances for Ttbio Corp., from to . As of , FDA records show no recalls naming K132570.

Clearance record

Decision date
Received
(257 days to decision)
Product code
EBW Controller, Foot, Handpiece And Cord
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Ttbio Corp. 2f, #7, 6th Rd. Industry Park, Taichung, Roc, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBW

Trailing 12 months
3 clearances under product code EBW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261