510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863009Substantially Equivalent

Gnatus Articulator 4.300/4.300Gp 8.600 & Ortoflex

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

K863009 is the FDA 510(k) clearance record for GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX, a class I device, cleared for Sds Dental, Inc. on under FDA product code EJP (Articulators). FDA records list 21 510(k) clearances for Sds Dental, Inc., from to . As of , FDA records show no recalls naming K863009.

Clearance record

Decision date
Received
(48 days to decision)
Product code
EJP Articulators
Regulation
21 CFR 872.3150
Device class
Class I
Review panel
Dental
Applicant
Sds Dental, Inc. 4321 Wisconsin Ave. N.W, Washington DC
Third party review
No

Clearances, product code EJP

Trailing 12 months

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

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