FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE DENTAL ROLL
K Number: K812709
·
Decision Oct 23, 1981
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
13
Applicant Total
15
Review Days
29
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Basic Information
- Device Name
- STERILE DENTAL ROLL
- K Number
- K812709
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Medspec Corp.
- Date Received
- September 24, 1981
- Decision Date
- October 23, 1981
- 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
FDA 510(k)
FDA Class 1
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COTTON ROLLS, NON-STERILE
FDA 510(k)
FDA Class 1
·Dental
DENTAL COTTON ROLLS, STERILE AND NON-STERILE
FDA 510(k)
FDA Class 1
·Dental
COTTON FILLED GAUZE SPONGES 2 X 2
FDA 510(k)
FDA Class 1
·Dental
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Medspec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K813012 | STERILE BASIN SETS | Nov 6, 1981 | Substantially Equivalent |
| K812711 | STERILE GAUZE PADS 12PLY | Nov 2, 1981 | Substantially Equivalent |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K810071 | STERILE SILICONE TUBING | Feb 12, 1981 | Substantially Equivalent |
| K810069 | STERILE AIRWAY | Feb 2, 1981 | Substantially Equivalent |
| K802060 | STERILE TONSIL SPONGES | Oct 10, 1980 | Substantially Equivalent |
| K801069 | STERILE ISOLATION GOWN | May 20, 1980 | Substantially Equivalent |
| K801068 | STERILE ABDOMINAL PAD | May 20, 1980 | Substantially Equivalent |
| K800278 | MEDSPEC SAFETY PINS | May 2, 1980 | Substantially Equivalent |