Synthograft Lg-Augmentation & Bone Fill
FDA 510(k) K821752 · Depuy, Inc.
510(k) numberK821752
Submission
- Device name
- Synthograft Lg-Augmentation & Bone Fill
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- June 15, 1982
- Decision date
- August 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Synthograft Lg-Augmentation & Bone Fill cleared by the FDA?
Synthograft Lg-Augmentation & Bone Fill (K821752) received a 510(k) decision of Substantially Equivalent on August 12, 1982, 58 days after the submission was received.
What is the product code of K821752?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.