FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTI-LITE
K Number: K844351
·
Decision Dec 21, 1984
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
6
Review Days
42
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Basic Information
- Device Name
- OPTI-LITE
- K Number
- K844351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Innovators, Inc.
- Date Received
- November 9, 1984
- Decision Date
- December 21, 1984
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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Other Clearances by Innovators, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921355 | WINGMASTER | Sep 25, 1992 | Substantially Equivalent |
| K921354 | BLUNT TIP IRRIGATION NEEDLES | Sep 25, 1992 | Substantially Equivalent |
| K921406 | SILICONT BUR BLOCK | Apr 28, 1992 | Substantially Equivalent |
| K830042 | E-Z JECTOR | Jan 26, 1983 | Substantially Equivalent |
| K790984 | KLIP-LITE | Oct 22, 1979 | Substantially Equivalent |