FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIESS-LUHR
K Number: K811113
·
Decision Jun 16, 1981
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
12
Applicant Total
1
Review Days
54
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Basic Information
- Device Name
- RIESS-LUHR
- K Number
- K811113
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4130
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Allomedic
- Date Received
- April 23, 1981
- Decision Date
- June 16, 1981
- Product Code
- DZA
- 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 |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | FDA class 1 | Dental |
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