510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902018Substantially Equivalent

Dentaurum Ceramic Debonding Unit

Dentauraum, Inc., Newtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902018 is the FDA 510(k) clearance record for DENTAURUM CERAMIC DEBONDING UNIT, a class I device, cleared for Dentauraum, Inc. on under FDA product code EKS (File, Pulp Canal, Endodontic). FDA records list 24 510(k) clearances for Dentauraum, Inc., from to . As of , FDA records show no recalls naming K902018.

Clearance record

Decision date
Received
(335 days to decision)
Product code
EKS File, Pulp Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Dentauraum, Inc. 2 Pheasant Run, Newtown PA
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