510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923461Substantially Equivalent

Pm2002 Proline, Pm2002 Proline Ec

Planmeca U.S.A. Inc, Finland, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923461 is the FDA 510(k) clearance record for PM2002 PROLINE, PM2002 PROLINE EC, a class I device, cleared for Planmeca USA, Inc. on under FDA product code KLC (Chair, Dental, With Operative Unit). FDA records list 13 510(k) clearances for Planmeca USA, Inc., from to . As of , FDA records show no recalls naming K923461.

Clearance record

Decision date
Received
(160 days to decision)
Product code
KLC Chair, Dental, With Operative Unit
Regulation
21 CFR 872.6250
Device class
Class I
Review panel
Dental
Applicant
Planmeca USA, Inc. Asentajasnkatu 6, Finland, FI
510(k) summary
Statement
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