510(k) K101481
K101481 is an FDA 510(k) premarket notification submitted by Biomers Products, LLC for the device "BIOMERS TRANSLUCENT ORTHODONTIC BRACKET". The FDA issued a decision of Substantially Equivalent on June 23, 2010. The device falls under product code NJM (Bracket, Ceramic, Orthodontic), a Class II device regulated under 21 CFR 872.5470. Biomers Products, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2010
- Date Received
- May 28, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Bracket, Ceramic, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
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.