510(k) K900507
- Device
- Disposable Screw Type Prophy Brush
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K900507
- Product code
- EHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-10
- Date received
- 1990-02-02
- 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
- JEFFERY LEHN
- Address
- 570 W. College Ave. P.O. Box 872 York PA US 17405 17405
FDA Registration Numbers#
- 3035858919
- 3011713204
- 3033011342
- 3012312751
- 1525838
- 3004753334
- 1061053
- 9680740
- 3012925629
- 3006990004
- 3038632739
- 3006174523
- 1420089
- 3007719760
- 3006847937
- 3011434305
- 2086043
- 3009381954
- 8010159
- 3011707926
- 3031582434
- 3009968482
- 3009049852
- 9615845
- 3043648115
- 3007279848
- 3008770655
- 3005558160
- 3010065389
- 3011554142
- 3021023132
- 8021050
- 8030938
- 2024949
- 3009171220
- 2511556
- 3011526299
- 3011632
- 2424472
- 9613208
- 2024980
- 3038718579
- 3004776555
- 3004046477
- 3023339277
- 3010864832
- 3003491259
- 3011300255
- 3006210673
- 2031508
- 3027234828
- 3009549523
- 3021386681
- 3008544850
- 3016426851
- 3011279497
- 9611367
- 3017498782
- 3004605493
- 3003965134
- 8040278
- 3006542438
- 3017220525
- 3009155756
- 8044167
- 8043962
- 3014926389
- 1032227
- 3004425647
- 3010656982
- 3008370577
- 1836161
- 3014345250
- 3015136927
- 1044031
- 3007255375
- 3008559238
- 3026326493
- 3004082121
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 |
| K864059 | DENTAL PROPHY CUPS (VARIOUS TYPES) | Mission White Dental, Inc. | 1986-11-19 |
| 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 |