Neo-Clip Orthodontic Bracket Accessory
FDA 510(k) K042905 · Dentsply Intl.
510(k) numberK042905
Submission
- Device name
- Neo-Clip Orthodontic Bracket Accessory
- Applicant
- Dentsply Intl.
York, PA, US - Received
- October 21, 2004
- Decision date
- November 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJM – Bracket, Ceramic, Orthodontic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Specialty
- Dental
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
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| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| 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 Neo-Clip Orthodontic Bracket Accessory cleared by the FDA?
Neo-Clip Orthodontic Bracket Accessory (K042905) received a 510(k) decision of Substantially Equivalent on November 4, 2004, 14 days after the submission was received.
What is the product code of K042905?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.