FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMALL INSTRUMENT STERILIZATION/BUR BOX
K Number: K910794
·
Decision May 23, 1991
Classifications
1
FEI Numbers
264
Registration Numbers
264
Same Product Code
26
Applicant Total
6
Review Days
87
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Basic Information
- Device Name
- SMALL INSTRUMENT STERILIZATION/BUR BOX
- K Number
- K910794
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3240
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Brevet, Inc.
- Date Received
- February 25, 1991
- Decision Date
- May 23, 1991
- Product Code
- EJL
- 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 |
|---|---|---|---|
| EJL | Bur, Dental | FDA class 1 | Dental |
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Other Clearances by Brevet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895958 | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) | Dec 4, 1989 | Substantially Equivalent |
| K895959 | BREVET FLOSS PICK (COLD STERILIZATION FLUIDS) | Nov 29, 1989 | Substantially Equivalent |
| K895753 | BREVET DISPOSABLE CONNECTORS | Nov 14, 1989 | Substantially Equivalent |
| K883126 | BREVET DENTAL INSTRUMENTS | Oct 5, 1988 | Substantially Equivalent |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Jul 28, 1988 | Substantially Equivalent |