FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BUTLER GUM PROPHY PASTE WITH NOVAMIN
K Number: K024343
·
Decision Jul 11, 2003
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- BUTLER GUM PROPHY PASTE WITH NOVAMIN
- K Number
- K024343
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Usbiomaterials Corp.
- Date Received
- December 27, 2002
- Decision Date
- July 11, 2003
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
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Other Clearances by Usbiomaterials Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K930115 | PERIOGLASS | Nov 4, 1993 | Substantially Equivalent |