510(k) K061397
K061397 is an FDA 510(k) premarket notification submitted by Ace Surgical Supply Co., Inc. for the device "ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M". The FDA issued a decision of Substantially Equivalent on August 16, 2006. The device falls under product code OAT (Implant, Endosseous, Orthodontic), a Class II device regulated under 21 CFR 872.3640. Ace Surgical Supply Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2006
- Date Received
- May 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.