510(k) K853005
- Device
- S.s. White Dental X-ray Film Holder & Aligning Arm
- Applicant
- THE S. S. WHITE CO.
- 510(k) number
- K853005
- Product code
- EGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-13
- Date received
- 1985-07-16
- Regulation
- 872.1905
- Classification name
- Holder, Film, X-Ray
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES D GOEBEL
- Address
- P.O. Box 100 Holmdel NJ US 07733 07733
FDA Registration Numbers#
- 3014398772
- 2182318
- 3033011342
- 3006316962
- 3012312751
- 3008361230
- 2023633
- 3007743883
- 3009161303
- 3014334038
- 3012925629
- 3022107311
- 3008346537
- 2086043
- 1051614
- 3004977335
- 2029234
- 3011326671
- 3025414363
- 3031582434
- 3020117925
- 3043648115
- 3012354669
- 3008770655
- 3004149016
- 3009703496
- 3015509619
- 3011554142
- 3013575574
- 3021023132
- 8030938
- 2024949
- 3009171220
- 1319130
- 1219313
- 3014937043
- 2424472
- 1718476
- 2024980
- 3038718579
- 3026400121
- 3010364969
- 3004046477
- 1036212
- 3031304584
- 3010864832
- 9680271
- 2031508
- 3027234828
- 3010288346
- 3013463240
- 3043226252
- 3005273623
- 3006055831
- 8040278
- 3008808049
- 3008770653
- 3017220525
- 3009155756
- 8043962
- 2431224
- 1032227
- 3004425647
- 3010656982
- 3008370577
- 3003418325
- 1836161
- 3009219448
- 3015136927
- 3009340886
- 3012101664
- 3011944170
- 1044031
- 1825309
- 3007255375
- 3010245461
- 3008559238
- 3024787345
- 3026326493
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EGZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K913160 | ID-TAB | Nix Co. , Ltd. | 1991-09-06 |
| K913168 | SALIBAG | Nix Co. , Ltd. | 1991-09-06 |
| K890355 | DENTAL X-RAY BITE BLOCK | Bite-A-Block | 1989-06-12 |
| K853451 | TROLL-BITE | Trollplast, Inc. | 1986-01-21 |
| K852170 | EZX YELLOW, BLUE OR ORANGE | Strong Marketing | 1985-09-05 |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Rinn Corp. | 1982-01-29 |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | Henry Schein, Inc. | 1980-05-20 |