| Primary Device ID | D06035442420 | 
| NIH Device Record Key | 3660bd2c-b1d6-4201-a427-dc1d2b0ea768 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Dentalez | 
| Version Model Number | 3544242 | 
| Company DUNS | 806326521 | 
| Company Name | Dentalez Alabama, Inc. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D06035442420 [Primary] | 
| EAZ | Light, Operating, Dental | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-11-13 | 
| Device Publish Date | 2024-11-05 | 
| D0603706275PT0 | NUSIMPLICITY CHAIR, 115V MAGL PRE-TUBED W/AIR GLIDE | 
| D0603706273RW0 | NUSIMPLICITY CHAIR, 115V WHITE | 
| D0603706273PT0 | NUSIMPLICITY CHAIR, 115V MAGL PRE-TUBED | 
| D06037062730 | NUSIMPLICITY CHAIR, 115V | 
| D06036553580 | CORE MAGELLAN UNIT | 
| D06036553570 | CORE CMU MOUNTED UNIT | 
| D0603655314G0 | SIMPLICITY MAGELLAN W/GALAXY HEAD | 
| D0603655313G0 | SIMPLICITY CMU W/GALAXY HEAD | 
| D06035442450 | POST MOUNT LESS RIGID ARM, SIMPLICITY LED 115V | 
| D06035442440 | SIMPLICITY LED, DUAL TRACK MOUNT 8'6" - 10', 115V | 
| D06035442430 | SIMPLICITY LED, DUAL TRACK MOUNT 8' - 8'6", 115V | 
| D06035442420 | SIMPLICITY LED, TRACK MOUNT, 8'6" - 10', 115V | 
| D06035442410 | SIMPLICITY LED, TRACK MOUNT, 8' - 8'6", 115V | 
| D06035442400 | SIMPLICITY LED, CABINET MOUNT, 115V | 
| D06035442390 | SIMPLICITY LED, WALL MOUNT, 115V | 
| D06035442380 | SIMPLICITY LED, CEILING MOUNT 8'- 8'6", 115V | 
| D06035442370 | SIMPLICITY LED, CEILING MOUNT 8'-6" TO 10'-0", 115V | 
| D06035442340 | SIMPLICITY LED, POST MOUNT 115V | 
| D06035442170 | SIMPLICITY CEILING MNT LIGHT, 115V, 8' | 
| D06035442160 | SP DUAL HEAD TRACK MOUNT LIGHT- 8'6" TO 10'0" 120V | 
| D06035442150 | SP DUAL HEAD TRACK MOUNT LIGHT- 8'0" TO 8'6" 120V | 
| D06035442080 | LIGHT, SIMPLICITY 220V WALL MOUNT | 
| D06035442070 | LIGHT, SIMPLICITY 120V WALL MOUNT | 
| D06035441940 | LIGHT, SIMP. TRACK MT. 8'6" TO 10'-0" 220V | 
| D06035441930 | LIGHT, SIMP. TRACK MT. 8'0" TO 8'-6" 220V | 
| D06035441920 | LIGHT, SIMP. TRACK MT. 8'6" TO 10'-0" 120V | 
| D06035441910 | LIGHT, SIMP. TRACK MT. 8'0" TO 8'-6" 120V | 
| D06035441900 | SIMPLICITY 220V CABINET MOUNT LIGHT | 
| D06035441880 | SIMPLICITY 220V CEILING MOUNT LIGHT | 
| D06035441870 | SIMPLICITY 115V CEILING MOUNT LIGHT, 8'6" TO 10' | 
| D06035441790 | SIMPLICITY LIGHT, 220V UNIT MOUNT | 
| D06035441780 | SIMPLICITY LIGHT, 115V UNIT MT W/TRANSFORMER | 
| D06035441770 | SIMPLICITY LIGHT, UNIT- NO TRANSFORMER | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DENTALEZ  74595082  1929886 Live/Registered | DENTALEZ, INC. 1994-11-04 | 
|  DENTALEZ  72110778  0736861 Live/Registered | DEN-TAL-EZ CHAIR MFG. CO. 1960-12-23 |