| Primary Device ID | 00817169024668 |
| NIH Device Record Key | 0fa2e086-27a9-48f4-ac3c-275e01ddcad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Essentials by 3D Dental |
| Version Model Number | HRCW-10 |
| Catalog Number | HRCW-10 |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
|---|---|
| GS1 | 00817169024668 [Primary] |
| LYU | Accessory, Surgical Apparel |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2023-01-09 |
| 00817169022732 | Essentials Powder free Ultra Nitrile Exam Gloves Size XL BOX/250 |
| 00817169022718 | Essentials Powder free Ultra Nitrile Exam Gloves Size Small BOX/300 |
| 10817169022685 | Essentials Powder free Ultra Nitrile Exam Gloves Size M BOX/300 |
| 00817169022671 | Essentials Powder free Ultra Nitrile Exam Gloves Size L Box of 300 |
| 00817169024040 | Cotton Tipped Applicators 6" 1000/Bx |
| 00817169024033 | Cotton Tipped Applicators 3" 1000/Bx |
| 00817169022978 | Patient Bibs 3PLY POLY 13X18 YELLOW 500/Case |
| 00817169022961 | Patient Bibs 3 PLY POLY 13X18 GRAY 500/Case |
| 00817169022954 | Patient Bibs 3PLY POLY 13X18 PEACH 500/Case |
| 00817169022947 | Patient Bibs 3 PLY POLY 13X18 TEAL 500/Case |
| 00817169022930 | Patient Bibs 3 PLY POLY 13X18 GREEN 500/Case |
| 00817169022923 | Patient Bibs 3PLY POLY 13X18 BEIGE 500/Case |
| 00817169022916 | Patient Bibs 3PLY POLY 13X18 MAUVE 500/Case |
| 00817169022909 | Patient Bibs 3PLY POLY 13X18 LAVENDER 500/Case |
| 00817169022893 | Patient Bibs 3PLY+POLY 13X18 WHITE 500/Case |
| 00817169022886 | Patient Bibs 3 PLY+POLY 13X18 BLUE 500/Case |
| 00817169022879 | Patient Bibs 2PLY+POLY 13X18 YELLOW 500/Case |
| 00817169022862 | Patient Bibs 2PLY+POLY 13X18 GRAY 500/Case |
| 00817169022855 | Patient Bibs 2PLY+POLY 13X18 PEACH 500/Case |
| 00817169022848 | Patient Bibs 2 PLY+POLY 13X18 TEAL 500/Case |
| 00817169022831 | Patient Bibs 2PLY+POLY 13X18 GREEN 500/Case |
| 00817169022824 | Patient Bibs 2PLY+POLY 13X18 BEIGE 500/Case |
| 00817169022817 | Patient Bibs 2PLY+POLY 13X18 MAUVE 500/Case |
| 00817169022800 | Patient Bibs 2 PLY+POLY 13X18 LAVENDER 500/case |
| 00817169022794 | Patient Bibs 2 Ply+Poly 13X18 WHITE 500/Case |
| 00817169022787 | Patient Bibs 2 PLY+POLY 13X18 BLUE 500/Case |
| 00817169029854 | The Essentials Tray Covers Ritter B 1000/Cs Green |
| 00817169029847 | The Essentials Tray Covers Ritter B 1000/Cs Lavender |
| 00817169029830 | The Essentials Tray Covers Ritter B 1000/Cs Mauve |
| 00817169029823 | The Essentials Tray Covers Ritter B 1000/Cs Blue |
| 00817169029816 | The Essentials Tray Covers Ritter B 1000/Cs White |
| 00810126504241 | ESSENTIALS PLASTIC CORE RAINBOW TIPS 250/BAG Economy |
| 00817169024958 | ESSENTIALS PRE BENT NEEDLE TIP 20G BLACK 100/Jar |
| 00817169023869 | Bib Clip 3/Pk Chain Yellow |
| 00817169023852 | Bib Clip 3/Pk Chain White |
| 00817169023845 | Bib Clip 3/Pk Chain Red |
| 00817169023838 | Bib Clip 3/Pk Plastic Non-Strech Yellow |
| 00817169023821 | Bib Clip 3/Pk Plastic Non-Strech White |
| 00817169023814 | Bib Clip 3/Pk Plastic Non-Strech Red |
| 00817169023807 | Bib Clip 3/Pk Plastic Non-Strech Purple |
| 00817169023791 | Bib Clip 3/Pk Plastic Non-Stretch Pink |
| 00817169023784 | Bib Clip 3/Pk Plastic Non-Stretch Peach |
| 00817169023777 | Bib Clip 3/Pk Plastic Non-Strech Green |
| 00817169023760 | Bib Clip 3/Pk Plastic Non-Strech Blue |
| 00817169023753 | Bib Clip 3/Pk Chain Green |
| 00817169023746 | Bib Clip 3/Pk Chain Blue |
| 00817169023739 | Bib Clip 3/Pk Chain Black |
| 00810126506542 | DISPOSABLE IMPRESSION TRAY #8 UPPER RIGHT/LOWER LEFT DOZEN |
| 00810126506504 | DISPOSABLE IMPRESSION TRAY #4 MEDIUM LOWER DOZEN |
| 00810126506498 | DISPOSABLE IMPRESSION TRAY #2 LARGE LOWER DOZEN |