FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TONGUE HOLDER/SALIVA EJECTOR
K Number: K800210
·
Decision Feb 6, 1980
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
17
Applicant Total
23
Review Days
5
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Basic Information
- Device Name
- TONGUE HOLDER/SALIVA EJECTOR
- K Number
- K800210
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Unitek Corp.
- Date Received
- February 1, 1980
- Decision Date
- February 6, 1980
- Product Code
- DYN
- 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 |
|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYN), ordered by most recent decision date.
DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR
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SALIVA EJECTOR DISPOSABLE
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HYGOFLEX SALIVA-EJECTOR
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EJECTOR
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HIGH VAC
FDA 510(k)
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MINIDAM
FDA 510(k)
FDA Class 1
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Other Clearances by Unitek Corp.
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|---|---|---|---|
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | Nov 29, 1994 | Substantially Equivalent |
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| K940165 | ALASTIK | Mar 7, 1994 | Substantially Equivalent |
| K923999 | ALASTIK NS | Jun 24, 1993 | Substantially Equivalent |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Nov 25, 1992 | Substantially Equivalent |
| K924295 | DEBRACKETING INSTRUMENT | Nov 23, 1992 | Substantially Equivalent |
| K923432 | GERMAN MINI DYNALOCK | Oct 30, 1992 | Substantially Equivalent |
| K911271 | ADHESIVE PRECOATED BRACKETS | May 29, 1991 | Substantially Equivalent |
| K910288 | NONSTAINING ALASTIKS | Mar 29, 1991 | Substantially Equivalent |
| K890529 | ALASTIGARD | Mar 9, 1989 | Substantially Equivalent |