FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAIF-BOW
K Number: K771706
·
Decision Sep 20, 1977
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
6
Review Days
11
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SAIF-BOW
- K Number
- K771706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Northwest Orthodontics, Inc.
- Date Received
- September 9, 1977
- Decision Date
- September 20, 1977
- Product Code
- DZB
- 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 |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZB), ordered by most recent decision date.
Orthodontic Facemask
FDA 510(k)
FDA Class 2
·Dental
Reverse Pull Adjustable Facemask
FDA 510(k)
FDA Class 2
·Dental
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
FDA 510(k)
FDA Class 2
·Dental
KJ MASK
FDA 510(k)
FDA Class 2
·Dental
NITOM LOCKING FACEBOW
FDA 510(k)
FDA Class 2
·Dental
EQUA-PULL SAFETY RELEASE MODULE
FDA 510(k)
FDA Class 2
·Dental
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 |
| K780814 | SAFETY STOP NECKSTRAP | Jun 30, 1978 | Substantially Equivalent |
| K780747 | SNAP-WAY | May 26, 1978 | Substantially Equivalent |
| K771095 | J HOOK HEADGEAR | Jun 24, 1977 | Substantially Equivalent |