510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K141183Substantially Equivalent

Evo 500 Series High Speed Handpieces/tiger 500/300/101 Series High Speed Handpieces

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

K141183 is the FDA 510(k) clearance record for EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES, a class I device, cleared for Ttbio Corp. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for Ttbio Corp., from to . As of , FDA records show no recalls naming K141183.

Clearance record

Decision date
Received
(296 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
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 EFB

Trailing 12 months
4 clearances under product code EFB 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 EFB, 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 20261
October 20261