510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983037Substantially Equivalent

Roeko Seal

Roeko Ulm, Roescheisen GmbH & Co., Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983037 is the FDA 510(k) clearance record for ROEKO SEAL, a class II device, cleared for Roeko Ulm, Roescheisen GmbH & Co. on under FDA product code KIF (Resin, Root Canal Filling). FDA records list one 510(k) clearance for Roeko Ulm, Roescheisen GmbH & Co. As of , FDA records show no recalls naming K983037.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KIF Resin, Root Canal Filling
Regulation
21 CFR 872.3820
Device class
Class II
Review panel
Dental
Applicant
Roeko Ulm, Roescheisen GmbH & Co. 100 Main St., Concord MA
510(k) summary
Summary
Third party review
No

Clearances, product code KIF

Trailing 12 months
6 clearances under product code KIF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20262
October 20260