510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863375Substantially Equivalent

Sea-Bond

Combe, Inc., White Plains NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863375 is the FDA 510(k) clearance record for SEA-BOND, a class I device, cleared for Combe, Inc. on under FDA product code KXX (Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer). FDA records list 3 510(k) clearances for Combe, Inc., from to . As of , FDA records show no recalls naming K863375.

Clearance record

Decision date
Received
(16 days to decision)
Product code
KXX Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Regulation
21 CFR 872.3450
Device class
Class I
Review panel
Dental
Applicant
Combe, Inc. 1101 Westchester Ave., White Plains NY
Third party review
No

Clearances, product code KXX

Trailing 12 months

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

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