FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISP. ABSORBENT COMPRESSED FIBRE WAFER
K Number: K770063
·
Decision Jan 14, 1977
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
13
Applicant Total
6
Review Days
3
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Basic Information
- Device Name
- DISP. ABSORBENT COMPRESSED FIBRE WAFER
- K Number
- K770063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lorvic Corp.
- Date Received
- January 11, 1977
- Decision Date
- January 14, 1977
- Product Code
- EFN
- 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 |
|---|---|---|---|
| EFN | Cotton, Roll | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFN), ordered by most recent decision date.
STRUNG DENTAL ROLLS
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MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
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COTTON ROLLS, NON-STERILE
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DENTAL COTTON ROLLS, STERILE AND NON-STERILE
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FDA Class 1
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COTTON FILLED GAUZE SPONGES 2 X 2
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FDA Class 1
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TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Lorvic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871615 | U. V. GERMICIDAL UNIT | Sep 11, 1987 | Substantially Equivalent |
| K780263 | SHIELD | May 3, 1978 | Substantially Equivalent |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Jan 14, 1977 | Substantially Equivalent |
| K760620 | SALIVA EJECTOR | Sep 21, 1976 | Substantially Equivalent |
| K760121 | IMPULSE HEAT SEALER | Jul 16, 1976 | Substantially Equivalent |