FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOOTHBRUSH, PEDODONTIC, #0126-0188-00
K Number: K771183
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- TOOTHBRUSH, PEDODONTIC, #0126-0188-00
- K Number
- K771183
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Hoyt Laboratories
- Date Received
- June 29, 1977
- Decision Date
- July 15, 1977
- Product Code
- EFW
- 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 |
|---|---|---|---|
| EFW | Toothbrush, Manual | FDA class 1 | Dental |
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MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
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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 |
| K810830 | HOYT COTTON ROLLS | Apr 14, 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 |