510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070290Substantially Equivalent

Spi Vectodrill Ceramic Drills

Thommen Medical AG, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070290 is the FDA 510(k) clearance record for SPI VECTODRILL CERAMIC DRILLS, a class I device, cleared for Thommen Medical AG on under FDA product code NDP (Accessories, Implant, Dental, Endosseous). FDA records list 26 510(k) clearances for Thommen Medical AG, from to . As of , FDA records show no recalls naming K070290.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NDP Accessories, Implant, Dental, Endosseous
Regulation
21 CFR 872.3980
Device class
Class I
Review panel
Dental
Applicant
Thommen Medical AG 11234 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDP

Trailing 12 months

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

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