FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARAGON
K Number: K991481
·
Decision Aug 11, 1999
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
14
Review Days
105
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Basic Information
- Device Name
- PARAGON
- K Number
- K991481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lancer Orthodontics, Inc.
- Date Received
- April 28, 1999
- Decision Date
- August 11, 1999
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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| K904090 | ORTHODONTIC BONDING ADHESIVE CONTROL | Apr 29, 1991 | Substantially Equivalent |
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| K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | Nov 5, 1990 | Substantially Equivalent |
| K904089 | PERMA MESH | Nov 2, 1990 | Substantially Equivalent |
| K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | Nov 2, 1990 | Substantially Equivalent |
| K902075 | INTRIGUE CERAMIC BRACKET | Aug 6, 1990 | Substantially Equivalent |