FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOYT COTTON ROLLS
K Number: K810830
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
13
Applicant Total
11
Review Days
20
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Basic Information
- Device Name
- HOYT COTTON ROLLS
- K Number
- K810830
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Hoyt Laboratories
- Date Received
- March 25, 1981
- Decision Date
- April 14, 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
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COTTON ROLLS, NON-STERILE
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DENTAL COTTON ROLLS, STERILE AND NON-STERILE
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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
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Other Clearances by Hoyt Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K820738 | LUSTRALLOY | Apr 9, 1982 | Substantially Equivalent |
| K811154 | HOYT ECONO-TRAY | May 13, 1981 | Substantially Equivalent |
| K780834 | PREVI DENT PROPHYLAXIS MINT NDC | Jun 2, 1978 | Substantially Equivalent |
| K771881 | REPLICA BONDING AGENT | Nov 9, 1977 | Substantially Equivalent |
| K771880 | REPLICA DENTAL COMPOSIT | Oct 20, 1977 | Substantially Equivalent |
| K771883 | REPLICA ACID-ETCH | Oct 20, 1977 | Substantially Equivalent |
| K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE | Oct 20, 1977 | Substantially Equivalent |
| K771185 | PERIODONTIC TOOTHBRUSH, #0126-0190-00 | Jul 15, 1977 | Substantially Equivalent |
| K771184 | TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 | Jul 15, 1977 | Substantially Equivalent |
| K771183 | TOOTHBRUSH, PEDODONTIC, #0126-0188-00 | Jul 15, 1977 | Substantially Equivalent |