FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-COMPANY ELASTIC LIGATURE RINGS
K Number: K852596
·
Decision Jul 31, 1985
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
24
Applicant Total
14
Review Days
42
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Basic Information
- Device Name
- A-COMPANY ELASTIC LIGATURE RINGS
- K Number
- K852596
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- A Company, Inc.
- Date Received
- June 19, 1985
- Decision Date
- July 31, 1985
- 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 A Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | May 31, 1990 | Substantially Equivalent |
| K852800 | A-COMPANY SELF-LIGATING APPLIANCE | Jul 31, 1985 | Substantially Equivalent |
| K852670 | A-COMPANY ESPREE SAFETY HEADGEAR | Jul 31, 1985 | Substantially Equivalent |
| K852599 | A-COMPANY ELASTOMERIC TUBING | Jul 31, 1985 | Substantially Equivalent |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | Jul 31, 1985 | Substantially Equivalent |
| K852598 | A-COMPANY SEPARATING ELASTICS | Jul 31, 1985 | Substantially Equivalent |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | Jul 31, 1985 | Substantially Equivalent |
| K851878 | A COMPANY BRASS SEPARATING RINGS | Jun 5, 1985 | Substantially Equivalent |
| K851454 | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS | Apr 29, 1985 | Substantially Equivalent |
| K844067 | VANISH ORTHODONTIC BRACKET | Nov 23, 1984 | Substantially Equivalent |