Product code EGZ
- Device name
- Holder, Film, X-Ray
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.1905
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | The S. S. White Co. | 1985-08-13 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D090101399150 | DEXIS IXS Size 2 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101399140 | DEXIS IXS Size 2 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461520 | DEXIS Titanium Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461510 | DEXIS Titanium Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461500 | DEXIS Titanium Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461490 | DEXIS Titanium Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461480 | DEXIS Titanium Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461070 | DEXIS IXS Size 1 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101399190 | DEXIS IXS Size 1 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101399180 | DEXIS IXS Size 1 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101399170 | DEXIS IXS Size 1 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101399160 | DEXIS IXS Size 2 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| D090101461090 | DEXIS IXS Size 2 Accessory Layer | Dental Imaging Technologies Corporation | 2026-08-03 |
| 00856145008926 | Two ClikrayONE Universal Holders WINE + Two G-Rings and Rods | CLIKTECH LLC | 2026-07-17 |
| 00840456222348 | JMU | JMU DENTAL, INC | 2026-06-08 |
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| 00840456221945 | JMU | JMU DENTAL, INC | 2026-06-08 |
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| 00840456221914 | JMU | JMU DENTAL, INC | 2026-06-08 |
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