FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIOGLASS
K Number: K930115
·
Decision Nov 4, 1993
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
5
Review Days
297
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Basic Information
- Device Name
- PERIOGLASS
- K Number
- K930115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Usbiomaterials Corp.
- Date Received
- January 11, 1993
- Decision Date
- November 4, 1993
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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Other Clearances by Usbiomaterials Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Jul 11, 2003 | Substantially Equivalent |
| K000149 | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE | Feb 7, 2000 | Substantially Equivalent |
| K992416 | PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE | Oct 15, 1999 | Substantially Equivalent |
| K962494 | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE | Sep 20, 1996 | Substantially Equivalent |