510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970042Substantially Equivalent

Ooli-U(tongue Scraper)

Telefax Intl., Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970042 is the FDA 510(k) clearance record for OOLI-U(TONGUE SCRAPER), a class I device, cleared for Telefax Intl. on under FDA product code LCN (Scraper, Tongue). FDA records list one 510(k) clearance for Telefax Intl. As of , FDA records show no recalls naming K970042.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LCN Scraper, Tongue
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Telefax Intl. 23704-5 El Toro Rd., Lake Forest CA
510(k) summary
Summary
Third party review
No

Clearances, product code LCN

Trailing 12 months

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

FDA records show no clearances under product code LCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCN, 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