510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897195Substantially Equivalent

A-Company Electrothermal Debonding Device (Etd)

A Company, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897195 is the FDA 510(k) clearance record for A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD), a class I device, cleared for A Company, Inc. on under FDA product code EKS (File, Pulp Canal, Endodontic). FDA records list 12 510(k) clearances for A Company, Inc., from to . As of , FDA records show no recalls naming K897195.

Clearance record

Decision date
Received
(153 days to decision)
Product code
EKS File, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
A Company, Inc. 11436 Sorrento Valley Rd., San Diego CA
Third party review
No

Clearances, product code EKS

Trailing 12 months

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

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