510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K070991Substantially Equivalent

Vita Cad-Temp for Inlab, Model, Vx59-4002, Vx59-4010, Vx59-4102, Vx59-4110, Vx59-4202, Vx59-4210, Vx59-4302, Vx59-4310

Vita, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K070991 is the FDA 510(k) clearance record for VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310, a class II device, cleared for Vita on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list one 510(k) clearance for Vita. As of , FDA records show no recalls naming K070991.

Clearance record

Decision date
Received
(53 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Vita 3150 E. Birch St., Brea CA
510(k) summary
Statement
Third party review
No

Clearances, product code EBG

Trailing 12 months
2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260