OSTEOGRAF/D-300
FDA 510(k) K072052 · Dentsply International, Inc.
510(k) numberK072052
Submission
- Device name
- OSTEOGRAF/D-300
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- July 26, 2007
- Decision date
- August 8, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was OSTEOGRAF/D-300 cleared by the FDA?
OSTEOGRAF/D-300 (K072052) received a 510(k) decision of Substantially Equivalent on August 8, 2007, 13 days after the submission was received.
What is the product code of K072052?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.