FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
K Number: K895959
·
Decision Nov 29, 1989
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
71
Applicant Total
6
Review Days
49
Basic Information
- Device Name
- BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
- K Number
- K895959
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- BREVET, INC.
- Date Received
- October 11, 1989
- Decision Date
- November 29, 1989
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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Other Clearances by BREVET, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | May 23, 1991 | Substantially Equivalent |
| K895958 | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) | Dec 4, 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 |