510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953865Substantially Equivalent

Spaceline Feel 21

J. Morita USA, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953865 is the FDA 510(k) clearance record for SPACELINE FEEL 21, a class I device, cleared for J. Morita USA, Inc. on under FDA product code EFA (Handpiece, Belt And/Or Gear Driven, Dental). FDA records list 52 510(k) clearances for J. Morita USA, Inc., from to . As of , FDA records show no recalls naming K953865.

Clearance record

Decision date
Received
(216 days to decision)
Product code
EFA Handpiece, Belt And/Or Gear Driven, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
J. Morita USA, Inc. 9 Mason, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code EFA

Trailing 12 months

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

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