FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURELLE II & LITE II-N72-N74-L
K Number: K833774
·
Decision Jan 24, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
25
Review Days
89
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Basic Information
- Device Name
- NATURELLE II & LITE II-N72-N74-L
- K Number
- K833774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Jeneric Ind.
- Date Received
- October 27, 1983
- Decision Date
- January 24, 1984
- 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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| K844123 | RX CBY | Jan 9, 1985 | Substantially Equivalent |
| K844122 | RX CBG | Jan 9, 1985 | Substantially Equivalent |
| K840563 | RX C & B 20 | May 1, 1984 | Substantially Equivalent |
| K840561 | RX ELAN | May 1, 1984 | Substantially Equivalent |
| K840562 | REX V | Apr 13, 1984 | Substantially Equivalent |
| K834560 | VITEX P.D.A | Feb 27, 1984 | Substantially Equivalent |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Dec 29, 1983 | Substantially Equivalent |