Osteograf/Ar+(Plus) Alveolar Rid Hydrox 18-40 Mesh
FDA 510(k) K861083 · Coors Biomedical Co.
510(k) numberK861083
Submission
- Device name
- Osteograf/Ar+(Plus) Alveolar Rid Hydrox 18-40 Mesh
- Applicant
- Coors Biomedical Co.
Lakewood, CO, US - Received
- March 21, 1986
- Decision date
- April 30, 1986
- 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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More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K863176 | Additional Clinical Usages for Osteograf/Ar & Ar+LYC · Traditional | 11/26/1986SN |
| K862324 | Osteograf/Ar and Osteograf/Ar+LYC · Traditional | 08/15/1986SE |
| K862061 | Osteograf/Ar+ Permaridge Hydroxylapatite, 18-40LYC · Traditional | 07/29/1986SE |
| K861084 | Osteograf/Ar Alveolar Rid Hydrox, 18-40 MeshLYC · Traditional | 04/30/1986SE |
| K852742 | Osteograf Ar Alveolar Ridge Hydroxylapatite 18-40LYC · Traditional | 09/26/1985SE |
| K810822 | Dental Porcelain PowderEIH · Traditional | 04/21/1981SE |
Questions and answers
When was Osteograf/Ar+(Plus) Alveolar Rid Hydrox 18-40 Mesh cleared by the FDA?
Osteograf/Ar+(Plus) Alveolar Rid Hydrox 18-40 Mesh (K861083) received a 510(k) decision of Substantially Equivalent on April 30, 1986, 40 days after the submission was received.
What is the product code of K861083?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.