510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896468Substantially Equivalent

Eos Bluephase-P and Redphase-P Impression Material

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

K896468 is the FDA 510(k) clearance record for EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL, a class II device, cleared for Ivoclar North America, Inc. on under FDA product code ELW (Material, Impression). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K896468.

Clearance record

Decision date
Received
(168 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260
November 20260