FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO PONTOSTAR
K Number: K983077
·
Decision Oct 23, 1998
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
7
Review Days
51
Basic Information
- Device Name
- BIO PONTOSTAR
- K Number
- K983077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BEGO U.S.A.
- Date Received
- September 2, 1998
- Decision Date
- October 23, 1998
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by BEGO U.S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K033279 | GOLD DENTAL CASTING ALLOYS | Jan 15, 2004 | Substantially Equivalent |
| K032136 | WIROBOND C | Sep 4, 2003 | Substantially Equivalent |
| K983082 | BEGOCER G | Oct 28, 1998 | Substantially Equivalent |
| K983080 | AUROLLOYD KF | Oct 28, 1998 | Substantially Equivalent |
| K983078 | BEGOPAL | Oct 23, 1998 | Substantially Equivalent |
| K983079 | PLATINLLOYD 100 | Oct 23, 1998 | Substantially Equivalent |