FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXIDENT
K Number: K821629
·
Decision Jun 14, 1982
Classifications
1
FEI Numbers
124
Registration Numbers
125
Same Product Code
14
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- FIXIDENT
- K Number
- K821629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6650
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Moyco Industries, Inc.
- Date Received
- June 2, 1982
- Decision Date
- June 14, 1982
- Product Code
- JET
- 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 |
|---|---|---|---|
| JET | Pick, Massaging | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JET), ordered by most recent decision date.
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
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ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
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ELECTRO FLOSS
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FDA Class 1
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GUM MASSAGER
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MASSAGING PICK FOR ORAL HYGIENE
FDA 510(k)
FDA Class 1
·Dental
PLAKOF
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Moyco Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932511 | SILICONE MIRROR | Nov 5, 1993 | Substantially Equivalent |
| K833558 | X-RAY SHIELD | Jan 13, 1984 | Substantially Equivalent |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Jun 14, 1982 | Substantially Equivalent |
| K810839 | SPOTAR | Apr 29, 1981 | Substantially Equivalent |
| K810912 | ALLOY COMPOSITE POLISH | Apr 23, 1981 | Substantially Equivalent |