FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHODONTIC ELASTOMER
K Number: K932319
·
Decision Sep 20, 1993
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
24
Applicant Total
13
Review Days
132
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Basic Information
- Device Name
- ORTHODONTIC ELASTOMER
- K Number
- K932319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gac Intl., Inc.
- Date Received
- May 11, 1993
- Decision Date
- September 20, 1993
- Product Code
- ECI
- 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 |
|---|---|---|---|
| ECI | Band, Elastic, 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 |
| 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 |
| K852179 | CERAMIC ORTHODONIT APPLIANCE | Aug 20, 1985 | Substantially Equivalent |