Bioglass Dental Endosseous Ridge Maintainer
FDA 510(k) K880371 · American Biomaterials Corp.
510(k) numberK880371
Submission
- Device name
- Bioglass Dental Endosseous Ridge Maintainer
- Applicant
- American Biomaterials Corp.
Plainsboro, NJ, US - Received
- January 27, 1988
- Decision date
- November 18, 1988
- 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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| K915824 | Hole PunchFOZ · Traditional | 01/29/1993SE |
| K863796 | Creative Care Systems' IV Start KitLRS · Traditional | 11/28/1986SE |
| K843461 | Bioglass Ossicular Reconstruction ProsthETA · Traditional | 01/09/1985SE |
Questions and answers
When was Bioglass Dental Endosseous Ridge Maintainer cleared by the FDA?
Bioglass Dental Endosseous Ridge Maintainer (K880371) received a 510(k) decision of Substantially Equivalent on November 18, 1988, 296 days after the submission was received.
What is the product code of K880371?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.