FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
K Number: K801688
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
22
Review Days
14
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Basic Information
- Device Name
- TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
- K Number
- K801688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pacific Dental Corp.
- Date Received
- July 21, 1980
- Decision Date
- August 4, 1980
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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|---|---|---|---|
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| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Jul 6, 1982 | Substantially Equivalent |
| K821777 | BEACH MOUTH MIRROR | Jul 6, 1982 | Substantially Equivalent |
| K821780 | BEACH EXPLORER NO. 23T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821785 | BEACH AMALGAM CARVER | Jul 6, 1982 | Substantially Equivalent |
| K821779 | BEACH AMALGAM CARRIER, GUN TYPE | Jul 6, 1982 | Substantially Equivalent |
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