510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884588Substantially Equivalent

Heliomolar(r) Dental Restorative

Williams Dental Co., Inc., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884588 is the FDA 510(k) clearance record for HELIOMOLAR(R) DENTAL RESTORATIVE, a class II device, cleared for Williams Dental Co., Inc. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 2 510(k) clearances for Williams Dental Co., Inc., from to . As of , FDA records show 4 recalls naming K884588.

Clearance record

Decision date
Received
(86 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Williams Dental Co., Inc. 2948 Main St., Buffalo NY
Third party review
No

Clearances, product code EBF

Trailing 12 months
19 clearances under product code EBF in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260