Ace Surgicalplaster Calcium Sulface Hemihydrate
FDA 510(k) K051381 · Ace Surgical Supply Co., Inc.
510(k) numberK051381
Submission
- Device name
- Ace Surgicalplaster Calcium Sulface Hemihydrate
- Applicant
- Ace Surgical Supply Co., Inc.
Brockton, MA, US - Received
- May 27, 2005
- Decision date
- July 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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| K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XXDZE · Special | 02/14/2008SE |
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…OAT · Traditional | 08/16/2006SE |
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Questions and answers
When was Ace Surgicalplaster Calcium Sulface Hemihydrate cleared by the FDA?
Ace Surgicalplaster Calcium Sulface Hemihydrate (K051381) received a 510(k) decision of Substantially Equivalent on July 15, 2005, 49 days after the submission was received.
What is the product code of K051381?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.