Interpore 200 Porous Hydroxyapatite
FDA 510(k) K860983 · Interpore Intl.
510(k) numberK860983
Submission
- Device name
- Interpore 200 Porous Hydroxyapatite
- Applicant
- Interpore Intl.
Irvine, CA, US - Received
- March 17, 1986
- Decision date
- May 23, 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.
Other 510(k)s with product code LYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253317 | Cytrans ElashieldLYC · Traditional | GC America, Inc. | 07/06/2026SE |
| 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 |
|---|---|---|
| K981253 | Ultracon UltrafiltratorFJI · Traditional | 12/11/1998SE |
| K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…MQV · Traditional | 09/25/1998SE |
| K972842 | Interpore Inducer Bone Graft Delivery SyringeLYC · Traditional | 10/30/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | 06/03/1997SE |
| K960945 | Imz Membrane Tack SystemDZL · Traditional | 05/24/1996SE |
| K960371 | Interpore Threaded ImplantDZE · Traditional | 03/08/1996SE |
| K955492 | Interpore Imz Cyl Implant & Cyl Hex ImpltDZE · Traditional | 01/30/1996SE |
| K952167 | Imz Bone Tack SystemDZL · Traditional | 11/21/1995SE |
| K950165 | Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000…LYC · Traditional | 03/28/1995SE |
| K922872 | Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 MM Diam.DZE · Traditional | 07/25/1994SE |
Questions and answers
When was Interpore 200 Porous Hydroxyapatite cleared by the FDA?
Interpore 200 Porous Hydroxyapatite (K860983) received a 510(k) decision of Substantially Equivalent on May 23, 1986, 67 days after the submission was received.
What is the product code of K860983?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.