FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K Number: K896501
·
Decision Feb 9, 1990
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
31
Review Days
87
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Basic Information
- Device Name
- TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
- K Number
- K896501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Leach and Dillon Co., Inc.
- Date Received
- November 14, 1989
- Decision Date
- February 9, 1990
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
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Other Clearances by Leach and Dillon Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903538 | WIRON 99 DENTAL CASTING ALLOY | Mar 15, 1991 | Substantially Equivalent |
| K903537 | 250 SL DENTAL CASTING ALLOY | Oct 24, 1990 | Substantially Equivalent |
| K895059 | HIGH FUSING YELLOW CERAMIC SOLDER | Oct 5, 1990 | Substantially Equivalent |
| K895058 | HIGH FUSING WHITE CERAMIC SOLDER | Oct 5, 1990 | Substantially Equivalent |
| K903484 | SELECT 20, DENTAL ALLOY | Sep 14, 1990 | Substantially Equivalent |
| K902372 | SILVER-FREE CERAMIC SOLDER (SFCS) | Jun 28, 1990 | Substantially Equivalent |
| K902373 | 200 SILHOUETTE LINE (SL) CERAMIC SOLDER | Jun 28, 1990 | Substantially Equivalent |
| K895888 | SILHOUETTE PORCELAIN | Apr 10, 1990 | Substantially Equivalent |
| K895889 | SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN) | Apr 4, 1990 | Substantially Equivalent |
| K895066 | MONOGRAM IV | Feb 14, 1990 | Substantially Equivalent |