Intra Lux Head 3 Ldsy
FDA 510(k) K092446 · Kaltenbach & Voigt GmbH & Co.
510(k) numberK092446
Submission
- Device name
- Intra Lux Head 3 Ldsy
- Applicant
- Kaltenbach & Voigt GmbH & Co.
Orange, CA, US - Received
- August 10, 2009
- Decision date
- November 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Intra Lux Head 3 Ldsy cleared by the FDA?
Intra Lux Head 3 Ldsy (K092446) received a 510(k) decision of Substantially Equivalent on November 3, 2009, 85 days after the submission was received.
What is the product code of K092446?
The FDA product code is EFA – Handpiece, Belt And/Or Gear Driven, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.