FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K Number: K895889
·
Decision Apr 4, 1990
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
31
Review Days
181
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Basic Information
- Device Name
- SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
- K Number
- K895889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Leach and Dillon Co., Inc.
- Date Received
- October 5, 1989
- Decision Date
- April 4, 1990
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | 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 |
| K895066 | MONOGRAM IV | Feb 14, 1990 | Substantially Equivalent |
| K896501 | TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS) | Feb 9, 1990 | Substantially Equivalent |