FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Exceed Tx
K Number: K150702
·
Decision Mar 24, 2016
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
13
Review Days
372
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Basic Information
- Device Name
- Exceed Tx
- K Number
- K150702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Great Lakes Orthodontics, Ltd.
- Date Received
- March 18, 2015
- Decision Date
- March 24, 2016
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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Other Clearances by Great Lakes Orthodontics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K172765 | Smart Moves Complete | Jun 1, 2018 | Substantially Equivalent |
| K083479 | BIOCRYL X | Feb 27, 2009 | Substantially Equivalent |
| K041718 | KELES FACEMASK | Oct 15, 2004 | Substantially Equivalent |
| K040881 | METACRYL | May 25, 2004 | Substantially Equivalent |
| K033632 | VARIFLEX | Jan 21, 2004 | Substantially Equivalent |
| K922818 | SNORE-NO-MORE | Feb 9, 1994 | Substantially Equivalent |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Jan 11, 1993 | Substantially Equivalent |
| K870908 | STEADY RESIN | Mar 19, 1987 | Substantially Equivalent |
| K861424 | ADAPTABLE CLASS III MASK | May 29, 1986 | Substantially Equivalent |
| K840805 | ORAL SAFE | Mar 30, 1984 | Substantially Equivalent |