510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990315Substantially Equivalent

Monopaque

Ivoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990315 is the FDA 510(k) clearance record for MONOPAQUE, a class II device, cleared for Ivoclar North America, Inc. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K990315.

Clearance record

Decision date
Received
(31 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
510(k) summary
Statement
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