510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880475Substantially Equivalent

Skema (Dental Unit)

Alpine Dental Equipment Co., East Orange NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880475 is the FDA 510(k) clearance record for SKEMA (DENTAL UNIT), a class I device, cleared for Alpine Dental Equipment Co. on under FDA product code KLC (Chair, Dental, With Operative Unit). FDA records list 10 510(k) clearances for Alpine Dental Equipment Co., from to . As of , FDA records show no recalls naming K880475.

Clearance record

Decision date
Received
(232 days to decision)
Product code
KLC Chair, Dental, With Operative Unit
Regulation
21 CFR 872.6250
Device class
Class I
Review panel
Dental
Applicant
Alpine Dental Equipment Co. 325 Elmwood Ave., East Orange NJ
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