Anterior Alveolar Ridge Sizer
FDA 510(k) K843153 · Interpore Intl.
510(k) numberK843153
Submission
- Device name
- Anterior Alveolar Ridge Sizer
- Applicant
- Interpore Intl.
Mchenry, IL, US - Received
- August 10, 1984
- Decision date
- September 27, 1984
- 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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| K981253 | Ultracon UltrafiltratorFJI · Traditional | 12/11/1998SE |
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| 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 Anterior Alveolar Ridge Sizer cleared by the FDA?
Anterior Alveolar Ridge Sizer (K843153) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 48 days after the submission was received.
What is the product code of K843153?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.