FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEW BASE FOR ORTHODONTIC APPLIANCES
K Number: K771774
·
Decision Sep 30, 1977
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
13
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
- NEW BASE FOR ORTHODONTIC APPLIANCES
- K Number
- K771774
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Gac Intl., Inc.
- Date Received
- September 19, 1977
- Decision Date
- September 30, 1977
- Product Code
- EJF
- 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJF), ordered by most recent decision date.
BITEM LOCK, MODELS SW006, SW012
FDA 510(k)
FDA Class 1
·Dental
MICROARCH GOLD BRACKET
FDA 510(k)
FDA Class 1
·Dental
ALASTIK
FDA 510(k)
FDA Class 1
·Dental
MEMORY WIRE
FDA 510(k)
FDA Class 1
·Dental
ORTHOTECH DURA-GOLD BARCKETS
FDA 510(k)
FDA Class 1
·Dental
FASCINATION CERAMIC BRACKET
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Gac Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981036 | SMARTBOND | Apr 5, 1999 | Substantially Equivalent |
| K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | Dec 14, 1994 | Substantially Equivalent |
| K933542 | MESIAL LOOP BAR | Aug 5, 1994 | Substantially Equivalent |
| K932825 | MICROARCH GOLD BRACKET | May 9, 1994 | Substantially Equivalent |
| K932319 | ORTHODONTIC ELASTOMER | Sep 20, 1993 | Substantially Equivalent |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Sep 13, 1993 | Substantially Equivalent |
| K920905 | BIOFORCE WIRE | Nov 4, 1992 | Substantially Equivalent |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Sep 28, 1992 | Substantially Equivalent |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | Aug 24, 1992 | Substantially Equivalent |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | Mar 20, 1992 | Substantially Equivalent |