Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth P

FDA 510(k) K102305 · Hass Corp.

Substantially Equivalent

510(k) numberK102305

Submission

Device name
Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth P
Applicant
Hass Corp.
Anaheim, CA, US
Received
August 16, 2010
Decision date
December 3, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIH – Powder, Porcelain
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6660
Specialty
Dental

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Questions and answers

When was Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth P cleared by the FDA?

Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth P (K102305) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 109 days after the submission was received.

What is the product code of K102305?

The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.