Pre-Cemented Orthodontic Bracket System Extension II
FDA 510(k) K093221 · Dentsply Intl., Inc.
510(k) numberK093221
Submission
- Device name
- Pre-Cemented Orthodontic Bracket System Extension II
- Applicant
- Dentsply Intl., Inc.
York, PA, US - Received
- October 13, 2009
- Decision date
- October 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
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Questions and answers
When was Pre-Cemented Orthodontic Bracket System Extension II cleared by the FDA?
Pre-Cemented Orthodontic Bracket System Extension II (K093221) received a 510(k) decision of Substantially Equivalent on October 30, 2009, 17 days after the submission was received.
What is the product code of K093221?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.