FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
K Number: K904092
·
Decision Nov 9, 1990
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
14
Review Days
64
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Basic Information
- Device Name
- LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
- K Number
- K904092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lancer Orthodontics, Inc.
- Date Received
- September 6, 1990
- Decision Date
- November 9, 1990
- 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 Lancer Orthodontics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122069 | STORM MINI SCREW | Apr 11, 2013 | Substantially Equivalent |
| K071192 | BLUGOO HD | Jun 22, 2007 | Substantially Equivalent |
| K051552 | O.A.S.I. SYSTEM | Sep 19, 2005 | Substantially Equivalent |
| K991481 | PARAGON | Aug 11, 1999 | Substantially Equivalent |
| K904090 | ORTHODONTIC BONDING ADHESIVE CONTROL | Apr 29, 1991 | Substantially Equivalent |
| K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | Nov 7, 1990 | Substantially Equivalent |
| 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 |