510(k) K864059
- Device
- DENTAL PROPHY CUPS (VARIOUS TYPES)
- Applicant
- MISSION WHITE DENTAL, INC.
- 510(k) number
- K864059
- Product code
- EHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-19
- Date received
- 1986-10-20
- Regulation
- 872.6290
- Classification name
- Cup, Prophylaxis
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH J BUTLER
- Address
- 31 Park Rd. Tinton Falls NJ US 07724 07724
FDA Registration Numbers#
- 9613208
- 8043962
- 1836161
- 9680740
- 3011526299
- 3006990004
- 3010864832
- 3008370577
- 3038632739
- 3009420946
- 3030126955
- 2086043
- 1044031
- 3009171220
- 3042244574
- 3016710511
- 2511556
- 3038718579
- 3011707926
- 3044150131
- 1061053
- 3012312751
- 3035858919
- 3008770655
- 3011300255
- 3023339277
- 2523320
- 3008544850
- 3007255375
- 3044819802
- 3017498782
- 2424472
- 3011632
- 3005558160
- 3004605493
- 9615845
- 3010583458
- 3004753334
- 3027234828
- 3008559238
- 3011279497
- 2024949
- 3009968482
- 1413787
- 3007279848
- 3045855232
- 3033011342
- 3007719760
- 3010656982
- 2024980
- 2435946
- 3010353847
- 3008352964
- 1718912
- 3003120666
- 3041928150
- 3021386681
- 8021050
- 3010065389
- 3003965134
- 8030938
- 1941138
- 3011434305
- 1032227
- 3008887731
- 2031508
- 3011554142
- 3017910185
- 3014345250
- 9611367
- 3014926389
- 1051594
- 3012494290
- 1450653
- 3017220525
- 3008559312
- 3006210673
- 3009381954
- 3016170492
- 3024088964
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EHK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953628 | PROPHY ANGLE | Rolence Enterprise Co. , Ltd. | 1995-09-29 |
| K951016 | DISPOSABLE PROPHYLAXIS ANGLE | Preventive Technologies, Inc. | 1995-05-02 |
| K900507 | DISPOSABLE SCREW TYPE PROPHY BRUSH | Dentsply Intl. | 1990-04-10 |
| K803155 | PROPHYLAXIS CUP. | Teledyne Densco | 1981-01-08 |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | 1978-02-16 |
| K770556 | PRO-KUP | Dental Control Products | 1977-03-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases