510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K180935Substantially Equivalent

Infinity / Infinity Cross Flex Dental Systems

Olsen Industria e Comercio S/a, Palhoça -, BR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K180935 is the FDA 510(k) clearance record for Infinity / Infinity Cross Flex Dental Systems, a class I device, cleared for Olsen Industria E Comercio S.A. on under FDA product code EIA (Unit, Operative Dental). FDA records list 2 510(k) clearances for Olsen Industria E Comercio S.A., from to . As of , FDA records show no recalls naming K180935.

Clearance record

Decision date
Received
(666 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Olsen Industria E Comercio S.A. Av. Ivo Luchi, 68 - Jardim Eldorado, Palhoça -, BR
510(k) summary
Statement
Third party review
No

Clearances, product code EIA

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