Exceed Tx
FDA 510(k) K150702 · Great Lakes Orthodontics, Ltd.
510(k) numberK150702
Submission
- Device name
- Exceed Tx
- Applicant
- Great Lakes Orthodontics, Ltd.
Tonawanda, NY, US - Received
- March 18, 2015
- Decision date
- March 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K160720 | Carriere Motion Clear Class IIDYW · Traditional | Ortho Organizers, Inc. | 11/28/2016SE |
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| K140807 | Composite Orthodontic BracketsDYW · Traditional | Ortho Specialties | 11/12/2014SE |
| K123118 | Insignia DigicastDYW · Traditional | Ormco Corp. | 03/26/2013SE |
| K123416 | Insignia with IteroDYW · Traditional | Ormco Corp. | 03/13/2013SE |
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| K041718 | Keles FacemaskDZB · Traditional | 10/15/2004SE |
| K040881 | MetacrylEBI · Traditional | 05/25/2004SE |
| K033632 | VariflexEBI · Traditional | 01/21/2004SE |
| 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 |
| K840805 | Oral SafeJER · Traditional | 03/30/1984SE |
Questions and answers
When was Exceed Tx cleared by the FDA?
Exceed Tx (K150702) received a 510(k) decision of Substantially Equivalent on March 24, 2016, 372 days after the submission was received.
What is the product code of K150702?
The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.