FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
K Number: K963699
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
12
Review Days
98
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Basic Information
- Device Name
- BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
- K Number
- K963699
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Belmont Equipment Corp.
- Date Received
- September 16, 1996
- Decision Date
- December 23, 1996
- Product Code
- EHD
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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Other Clearances by Belmont Equipment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000799 | BELMONT UNIT, MODEL 2000 SERIES | May 17, 2000 | Substantially Equivalent |
| K983661 | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES | Jan 12, 1999 | Substantially Equivalent |
| K900681 | PANORAMIC MODEL X-CALIBER X-RAY | May 23, 1990 | Substantially Equivalent |
| K874238 | MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY | Dec 7, 1987 | Substantially Equivalent |
| K870300 | BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 | Mar 25, 1987 | Substantially Equivalent |
| K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY | Apr 24, 1986 | Substantially Equivalent |
| K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD | Jun 5, 1985 | Substantially Equivalent |
| K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | Feb 21, 1985 | Substantially Equivalent |
| K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY | Dec 29, 1983 | Substantially Equivalent |
| K832065 | ACURACY 071, DENTAL, INTRAORAL-X-RAY | Sep 12, 1983 | Substantially Equivalent |