FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURA-TONE OR LUXOPAL CL ACRYLIC
K Number: K842208
·
Decision Jul 31, 1984
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
14
Review Days
57
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Basic Information
- Device Name
- NATURA-TONE OR LUXOPAL CL ACRYLIC
- K Number
- K842208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- June 4, 1984
- Decision Date
- July 31, 1984
- Product Code
- ELM
- 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 |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
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|---|---|---|---|
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| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
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| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Aug 20, 1985 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |