PLASTICEPH
FDA 510(k) clearance K810538 · decided 1981-04-29
Clearance details
- K-number
- K810538
- Device name
- PLASTICEPH
- Applicant
- Morningstar Dental Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-26
- Decision date
- 1981-04-29
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- EAG
- Device class
- 2
- Regulation number
- 872.1830
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (K030699) | J. Morita Mfg. Corp. | 2003-05-29 |
| VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (K021372) | J. Morita USA, Inc. | 2002-06-07 |
| DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (K944162) | Teledyne Water Pik | 1994-11-29 |
| GX-C CEPHALOMETER (K920189) | Gendex Corp. | 1992-04-28 |
| DIGIGRAPH DIAGNOSTIC WORK/STATION (K896099) | Dolphin Imaging Systems | 1991-01-31 |
| BURNETT TMJ APPLIANCE (K870243) | Medrad, Inc. | 1987-02-24 |
| GX CEPH (K842463) | Gendex Corp. | 1984-08-02 |
| CEPHALOMETER & FIXATOR (K833006) | Modern Systems, Inc. | 1984-01-03 |
| DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (K781287) | Siemens Corp. | 1978-09-11 |
Recalls involving this device
No recalls on record reference this clearance.