510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863008Substantially Equivalent

-Om West 2000 Gnatus Chair

Sds Dental, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863008 is the FDA 510(k) clearance record for -OM WEST 2000 GNATUS CHAIR, a class I device, cleared for Sds Dental, Inc. on under FDA product code HME (Chair, Ophthalmic, Ac-Powered). FDA records list 21 510(k) clearances for Sds Dental, Inc., from to . As of , FDA records show no recalls naming K863008.

Clearance record

Decision date
Received
(47 days to decision)
Product code
HME Chair, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1140
Device class
Class I
Review panel
Ophthalmic
Applicant
Sds Dental, Inc. 4321 Wisconsin Ave. N.W, Washington DC
Third party review
No

Clearances, product code HME

Trailing 12 months

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

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