FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GREAT LAKES PASTE SOLDER
K Number: K832425
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
13
Review Days
74
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Basic Information
- Device Name
- GREAT LAKES PASTE SOLDER
- K Number
- K832425
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Great Lakes Orthodontics, Ltd.
- Date Received
- July 22, 1983
- Decision Date
- October 4, 1983
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
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| K922818 | SNORE-NO-MORE | Feb 9, 1994 | Substantially Equivalent |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Jan 11, 1993 | Substantially Equivalent |
| K870908 | STEADY RESIN | Mar 19, 1987 | Substantially Equivalent |
| K861424 | ADAPTABLE CLASS III MASK | May 29, 1986 | Substantially Equivalent |