FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORAL SAFE
K Number: K840805
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
13
Applicant Total
13
Review Days
35
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Basic Information
- Device Name
- ORAL SAFE
- K Number
- K840805
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3530
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Great Lakes Orthodontics, Ltd.
- Date Received
- February 24, 1984
- Decision Date
- March 30, 1984
- Product Code
- JER
- 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 |
|---|---|---|---|
| JER | Cleaner, Denture, Mechanical | FDA class 1 | Dental |
Similar 510(k) Clearances
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Other Clearances by Great Lakes Orthodontics, Ltd.
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|---|---|---|---|
| K172765 | Smart Moves Complete | Jun 1, 2018 | Substantially Equivalent |
| K150702 | Exceed Tx | Mar 24, 2016 | 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 |