Bio-Oss Pure Nat Hydroxyapatite Endoss Implant
FDA 510(k) K871773 · Geistlich-Pharma
510(k) numberK871773
Submission
- Device name
- Bio-Oss Pure Nat Hydroxyapatite Endoss Implant
- Applicant
- Geistlich-Pharma
Washington, DC, US - Received
- May 6, 1987
- Decision date
- August 24, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 Bio-Oss Pure Nat Hydroxyapatite Endoss Implant cleared by the FDA?
Bio-Oss Pure Nat Hydroxyapatite Endoss Implant (K871773) received a 510(k) decision of Substantially Equivalent for Some Indications on August 24, 1987, 110 days after the submission was received.
What is the product code of K871773?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.