FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CERAMIC ORTHODONIT APPLIANCE
K Number: K852179
·
Decision Aug 20, 1985
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
13
Review Days
92
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Basic Information
- Device Name
- CERAMIC ORTHODONIT APPLIANCE
- K Number
- K852179
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Gac Intl., Inc.
- Date Received
- May 20, 1985
- Decision Date
- August 20, 1985
- 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 |
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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 |