Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)
FDA 510(k) K002469 · W&H Dentalwerk Buermoos GmbH
510(k) numberK002469
Submission
- Device name
- Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- August 11, 2000
- Decision date
- February 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) cleared by the FDA?
Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) (K002469) received a 510(k) decision of Substantially Equivalent on February 7, 2001, 180 days after the submission was received.
What is the product code of K002469?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.