510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771406Substantially Equivalent

Gutta Gun

Aus-Tex Dental Mfg. & Design, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771406 is the FDA 510(k) clearance record for GUTTA GUN, a class I device, cleared for Aus-Tex Dental Mfg. & Design on under FDA product code EIC (Syringe, Periodontic, Endodontic, Irrigating). FDA records list 3 510(k) clearances for Aus-Tex Dental Mfg. & Design, from to . As of , FDA records show no recalls naming K771406.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EIC Syringe, Periodontic, Endodontic, Irrigating
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Aus-Tex Dental Mfg. & Design 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EIC

Trailing 12 months

FDA records hold no clearances under product code EIC in the trailing twelve months.

FDA records show no clearances under product code EIC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EIC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260