510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983876Substantially Equivalent

Millenium Sledgehammer, Formula 99 and Naturalyke H.c., High Impact Denture Acrylic

Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind, Cherry Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983876 is the FDA 510(k) clearance record for MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC, a class II device, cleared for Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind. As of , FDA records show no recalls naming K983876.

Clearance record

Decision date
Received
(44 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind 616 Hollywood Ave., Cherry Hill NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260