FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTIX DENTAL X-RAY UNIT
K Number: K792307
·
Decision Jan 9, 1980
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
41
Applicant Total
13
Review Days
54
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Basic Information
- Device Name
- DENTIX DENTAL X-RAY UNIT
- K Number
- K792307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Precise Optics
- Date Received
- November 16, 1979
- Decision Date
- January 9, 1980
- Product Code
- EAP
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | FDA class 2 | Dental |
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|---|---|---|---|
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| K932878 | PRECISION INTRA-ORAL SCOPES | Jan 6, 1994 | Substantially Equivalent |
| K914084 | ENDOSCOPES | Jan 22, 1992 | Substantially Equivalent |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 | Substantially Equivalent |
| K911744 | PRECISION OPTICS CORPORATION LAPAROSCOPE | Jul 26, 1991 | Substantially Equivalent |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Oct 26, 1990 | Substantially Equivalent |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Oct 19, 1990 | Substantially Equivalent |
| K903458 | PRECISION OPTICS IMAGE COUPLER | Oct 19, 1990 | Substantially Equivalent |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |