FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLTENE BRILLIANT LUX
K Number: K840084
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
11
Review Days
80
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Basic Information
- Device Name
- COLTENE BRILLIANT LUX
- K Number
- K840084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Bauer, Cheng & Associates, Inc.
- Date Received
- January 10, 1984
- Decision Date
- March 30, 1984
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Bauer, Cheng & Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K840085 | COLTENE BRILLIANT | Mar 16, 1984 | Substantially Equivalent |
| K823098 | REX-CAPS | Nov 10, 1982 | Substantially Equivalent |
| K823100 | RX 91 | Nov 10, 1982 | Substantially Equivalent |
| K823097 | NATURELLE | Nov 10, 1982 | Substantially Equivalent |
| K823099 | RX MIDACAST | Nov 10, 1982 | Substantially Equivalent |
| K823084 | CHALLENGER | Nov 10, 1982 | Substantially Equivalent |
| K810970 | ISOSIT TEETH | May 5, 1981 | Substantially Equivalent |
| K810971 | THE GNATOMET | May 5, 1981 | Substantially Equivalent |
| K810972 | THE GNATHOMETER-M | May 5, 1981 | Substantially Equivalent |
| K810969 | ISOSIT C & B MATERIAL | May 5, 1981 | Substantially Equivalent |