510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844480Substantially Equivalent for Some Indications

Dental Oral Care Systems & Components

Advanced Bio Systems, Inc., Valley Stream NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K844480 is the FDA 510(k) clearance record for DENTAL ORAL CARE SYSTEMS & COMPONENTS, a class II device, cleared for Advanced Bio Systems, Inc. on under FDA product code EBO (Denture Repair Kit). FDA's definition for product code EBO reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 2 510(k) clearances for Advanced Bio Systems, Inc., from to . As of , FDA records show no recalls naming K844480.

Clearance record

Decision date
Received
(212 days to decision)
Product code
EBO Denture Repair Kit
Regulation
21 CFR 872.3570
Device class
Class II
Review panel
Dental
Applicant
Advanced Bio Systems, Inc. 80 E. Hawthorne Ave., Valley Stream NY
Third party review
No

Clearances, product code EBO

Trailing 12 months

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

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