510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893454Substantially Equivalent

Chair/stool Unit Dental Oper., Portable, Field

Atlantic Industries, Inc., Hardeevile SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893454 is the FDA 510(k) clearance record for CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD, a class I device, cleared for Atlantic Industries, Inc. on under FDA product code KLC (Chair, Dental, With Operative Unit). FDA records list one 510(k) clearance for Atlantic Industries, Inc. As of , FDA records show no recalls naming K893454.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KLC Chair, Dental, With Operative Unit
Regulation
21 CFR 872.6250
Device class
Class I
Review panel
Dental
Applicant
Atlantic Industries, Inc. P.O. Box 1169, Hardeevile SC
Third party review
No

Clearances, product code KLC

Trailing 12 months

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

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