Accessory to Improved Dental Operating Light
FDA 510(k) K925629 · Den-Tal-Ez Mfg Co., Inc.
510(k) numberK925629
Submission
- Device name
- Accessory to Improved Dental Operating Light
- Applicant
- Den-Tal-Ez Mfg Co., Inc.
Lancaster, PA, US - Received
- November 6, 1992
- Decision date
- November 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K902685 | Defiance Model Fus 336EAZ · Traditional | Defiance Electronics, Inc. | 09/17/1990SE |
More from Defiance Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K932824 | Evacuator, Oral CavityEIA · Traditional | 09/28/1993SE |
| K931204 | AS3000 Operative Dental Unit (Delivery System)EIA · Traditional | 07/08/1993SE |
| K920017 | Improved Dental Operating LightKLC · Traditional | 03/02/1992SE |
| K920016 | Improved Dental ChairKLC · Traditional | 03/02/1992SE |
| K874294 | Autochuck AttachmentEFB · Traditional | 12/29/1987SE |
| K780469 | Panoramic X-Ray, DentalEHD · Traditional | 04/10/1978SE |
Questions and answers
When was Accessory to Improved Dental Operating Light cleared by the FDA?
Accessory to Improved Dental Operating Light (K925629) received a 510(k) decision of Substantially Equivalent on November 23, 1993, 382 days after the submission was received.
What is the product code of K925629?
The FDA product code is EAZ – Light, Operating, Dental, a Class I (low risk) device regulated under 21 CFR 872.4630.