FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFETY STOP NECKSTRAP
K Number: K780814
·
Decision Jun 30, 1978
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
3
Applicant Total
6
Review Days
43
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Basic Information
- Device Name
- SAFETY STOP NECKSTRAP
- K Number
- K780814
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5525
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Northwest Orthodontics, Inc.
- Date Received
- May 18, 1978
- Decision Date
- June 30, 1978
- Product Code
- DYT
- 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 |
|---|---|---|---|
| DYT | Maintainer, Space Preformed, Orthodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYT), ordered by most recent decision date.
DENTAURUM SPACE MAINTAINER
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FIBERBOND
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UNITEK PALATAL BAR
FDA 510(k)
FDA Class 1
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Other Clearances by Northwest Orthodontics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800748 | SNAP-WAY HEADGEAR | Apr 10, 1980 | Substantially Equivalent |
| K790843 | SNAP-WAY | May 31, 1979 | Substantially Equivalent |
| K780747 | SNAP-WAY | May 26, 1978 | Substantially Equivalent |
| K771706 | SAIF-BOW | Sep 20, 1977 | Substantially Equivalent |
| K771095 | J HOOK HEADGEAR | Jun 24, 1977 | Substantially Equivalent |