510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K980018Substantially Equivalent

Cristobal

Newave Medical, Inc., Wellesley MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980018 is the FDA 510(k) clearance record for CRISTOBAL, a class II device, cleared for Newave Medical, Inc. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list one 510(k) clearance for Newave Medical, Inc. As of , FDA records show no recalls naming K980018.

Clearance record

Decision date
Received
(137 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Newave Medical, Inc. 70 Walnut St., Wellesley MA
510(k) summary
Summary
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