510(k) K872098
- Device
- CREMEEN ALVEOLAR BONE CALIPER
- Applicant
- BOWEN & COMPANY, INC.
- 510(k) number
- K872098
- Product code
- EIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-31
- Date received
- 1987-06-01
- Regulation
- 872.4565
- Classification name
- Gauge, Depth, Instrument, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN L BRANDT
- Address
- 1800 Chapman Ave. Rockville MD US 20852 20852
FDA Registration Numbers#
- 3009968482
- 3015136927
- 3011936113
- 8010155
- 3001778198
- 3003969055
- 3003678542
- 9611274
- 3005061536
- 3005092287
- 9613079
- 2081322
- 1416605
- 3001620590
- 3005621335
- 9611367
- 2126683
- 1836161
- 3011575061
- 3013271380
- 2246990
- 9680939
- 3011511773
- 3001146947
- 3009887475
- 3004417597
- 3006444232
- 3017138012
- 1828464
- 3008808049
- 3010032042
- 3016965929
- 8030938
- 3008959450
- 3008346537
- 3013463240
- 9611458
- 9616128
- 3005528784
- 9614986
- 1316092
- 3012477813
- 3010288346
- 2918719
- 3003882387
- 3044150131
- 8040278
- 3003582728
- 9615399
- 3009171220
- 3003963832
- 9680026
- 1223843
- 1032347
- 8010704
- 3004578807
- 3012494290
- 1723412
- 3005809810
- 3021023132
- 2521453
- 3014540272
- 2529846
- 9680913
- 3013508670
- 3009703496
- 1032227
- 3021666757
- 9611450
- 8043992
- 8010159
- 3007284437
- 3008496301
- 9681540
- 8043554
- 3007649394
- 3016447764
- 8040288
- 3012084431
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EIL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911643 | ABIODENT PERIOTEMP(R) SYSTEM | Abiomed, Inc. | 1991-07-09 |
| K890493 | FLORIDA PROBE PERIODONTAL PROBE | Florida Probe Corp. | 1989-03-13 |
| K885075 | ABIOMED PERIOTEMP(TM) PROBE | Abiomed, Inc. | 1989-02-13 |
| K884813 | MODEL 200A ELECTRONIC FORCE-SENSING PROBE | Vine Valley Research | 1989-01-05 |
| K880209 | PERIODONTAL PROBE - AUTOPROBE | Dentsply Intl. | 1988-04-27 |
| K872215 | PERIO-TEST | Dr. Bernard Loewenthal | 1987-07-10 |
| K822793 | PIO ROOT CANAL INDICATOR | National Patent Development Corp. | 1982-10-22 |
Legacy Summary#
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FDA Review#
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