HA-1000 & HA-500 Hydroxylapatite Tooth Root Substi
FDA 510(k) K852766 · Orthomatrix, Inc.
510(k) numberK852766
Submission
- Device name
- HA-1000 & HA-500 Hydroxylapatite Tooth Root Substi
- Applicant
- Orthomatrix, Inc.
Dublin, CA, US - Received
- June 28, 1985
- Decision date
- October 21, 1985
- 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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| K253883 | Bonalive MaxillofacialLYC · Special | Bonalive , Ltd. | 05/14/2026SE |
| K251818 | Bontree PlusLYC · Traditional | Hudens Bio Co., Ltd. | 03/06/2026SE |
| K244006 | FG Bone Graft MLYC · Traditional | Full Golden Biotech Co., Ltd. | 09/17/2025SE |
| K243745 | FG Bone Graft BLYC · Traditional | Full Golden Biotech Corporation | 08/29/2025SE |
| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
| K202675 | InRoad® Dental Synthetic Bone GraftLYC · Traditional | Osteogene Tech Corp | 03/04/2022SE |
| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | Institut Straumann AG | 09/24/2020SE |
More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K010738 | Cannulated Plus Screw SystemHWC · Traditional | 08/01/2001SE |
| K001254 | Orthomatrix, Inc. Cerclage SystemJDQ · Traditional | 12/13/2000SE |
| K992856 | Magellan Humeral Intramedullary NailHSB · Traditional | 03/10/2000SE |
| K992850 | Magellan Tibial Intramedullary NailHSB · Traditional | 03/10/2000SE |
| K852765 | HA-2000 HydroxylapatiteLYC · Traditional | 09/23/1985SE |
| K851367 | HA-1000 & HA-500 Hydroxylapatite-ModificationDZE · Traditional | 05/21/1985SE |
| K842163 | Ridgematrix 20/40 Mesh, PeriomatrixLYC · Traditional | 08/09/1984SE |
Questions and answers
When was HA-1000 & HA-500 Hydroxylapatite Tooth Root Substi cleared by the FDA?
HA-1000 & HA-500 Hydroxylapatite Tooth Root Substi (K852766) received a 510(k) decision of Substantially Equivalent on October 21, 1985, 115 days after the submission was received.
What is the product code of K852766?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.