Keles Facemask
FDA 510(k) K041718 · Great Lakes Orthodontics, Ltd.
510(k) numberK041718
Submission
- Device name
- Keles Facemask
- Applicant
- Great Lakes Orthodontics, Ltd.
Tonawanda, NY, US - Received
- June 24, 2004
- Decision date
- October 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K993224 | T-Gear, Model TG/400-700DZB · Traditional | Dontech Products B.V. | 02/11/2000SE |
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| K922818 | Snore-No-MoreLQZ · Traditional | 02/09/1994SE |
| K925275 | Soft Denture Reline Material ElastolineEBI · Traditional | 01/11/1993SE |
| K870908 | Steady ResinEBI · Traditional | 03/19/1987SE |
| K861424 | Adaptable Class III MaskDZB · Traditional | 05/29/1986SE |
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Questions and answers
When was Keles Facemask cleared by the FDA?
Keles Facemask (K041718) received a 510(k) decision of Substantially Equivalent on October 15, 2004, 113 days after the submission was received.
What is the product code of K041718?
The FDA product code is DZB – Headgear, Extraoral, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5500.