Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns
FDA 510(k) K950165 · Interpore Intl.
510(k) numberK950165
Submission
- Device name
- Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns
- Applicant
- Interpore Intl.
Irvine, CA, US - Received
- January 17, 1995
- Decision date
- March 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
| K922872 | Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 MM Diam.DZE · Traditional | 07/25/1994SE |
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Questions and answers
When was Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns cleared by the FDA?
Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns (K950165) received a 510(k) decision of Substantially Equivalent on March 28, 1995, 70 days after the submission was received.
What is the product code of K950165?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.