| Primary Device ID | 00844868048497 |
| NIH Device Record Key | 02d3885d-67e9-4f90-9a8a-7fb18f7a7b7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Immediate Molar |
| Version Model Number | IMDI9 |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com | |
| Phone | +1(800)342-5454 |
| DentalCS@zimvie.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868048497 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
[00844868048497]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
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| 00844868048213 | Immediate Molar Shaping Drill 7mmD, 6mmL |
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| 00844868048152 | Immediate Molar Shaping Drill 6mmD, 8mmL |
| 00844868048138 | Immediate Molar Shaping Drill 6mmD, 6mmL |
| 00844868048121 | Immediate Molar Shaping Drill 6mmD, 11.5mmL |
| 00844868048107 | Immediate Molar Shaping Drill 6mmD, 10mmL |
| 00844868048084 | Immediate Molar Shaping Drill 5.4mmD, 8mmL |
| 00844868048060 | Immediate Molar Shaping Drill 5.4mmD, 6mmL |
| 00844868048046 | Immediate Molar Tapered Drill T3® PRO 5.1mmD |
| 00844868048022 | Immediate Molar Shaping Drill 5.4mmD, 11.5mmL |
| 00844868048008 | Immediate Molar Shaping Drill 5.4mmD, 10mmL |
| 00844868047988 | Immediate Molar Tapered Drill TSX® 4.4mmD |
| 00844868047964 | Immediate Molar Tapered Drill T3® PRO 4.4mmD |
| 00844868047940 | Immediate Molar Tapered Drill TSX® 3.8mmD |
| 00844868047926 | Immediate Molar Tapered Drill T3® PRO 3.8mmD |
| 00844868047902 | Immediate Molar Tapered Drill TSX® 3.4mmD |
| 00844868047889 | Immediate Molar Tapered Drill T3® PRO 3.4mmD |
| 00844868047865 | Immediate Molar Starter Drill 2.8mmD Short |
| 00844868047841 | Immediate Molar Starter Drill 2.8mmD Long |
| 00844868048404 | Single Patient Immediate Molar Shaping Drill 9mmD, 8mmL |
| 00844868048398 | Immediate Molar Shaping Drill 9mmD, 8mmL |
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| 00844868048374 | Immediate Molar Shaping Drill 9mmD, 6mmL |
| 00844868048367 | Single Patient Immediate Molar Shaping Drill 9mmD, 11.5mmL |
| 00844868048350 | Immediate Molar Shaping Drill 9mmD, 11.5mmL |
| 00844868048343 | Single Patient Immediate Molar Shaping Drill 9mmD, 10mmL |
| 00844868048336 | Immediate Molar Shaping Drill 9mmD, 10mmL |
| 00844868048329 | Single Patient Immediate Molar Shaping Drill 8mmD, 8mmL |
| 00844868048305 | Single Patient Immediate Molar Shaping Drill 8mmD, 6mmL |
| 00844868048282 | Single Patient Immediate Molar Shaping Drill 8mmD, 11.5mmL |
| 00844868048275 | Immediate Molar Shaping Drill 8mmD, 11.5mmL |
| 00844868048268 | Single Patient Immediate Molar Shaping Drill 8mmD, 10mmL |
| 00844868048251 | Immediate Molar Shaping Drill 8mmD, 10mmL |
| 00844868048244 | Single Patient Immediate Molar Shaping Drill 7mmD, 8mmL |
| 00844868048220 | Single Patient Immediate Molar Shaping Drill 7mmD, 6mmL |
| 00844868048206 | Single Patient Immediate Molar Shaping Drill 7mmD, 11.5mmL |
| 00844868048183 | Single Patient Immediate Molar Shaping Drill 7mmD, 10mmL |
| 00844868048169 | Single Patient Immediate Molar Shaping Drill 6mmD, 8mmL |
| 00844868048145 | Single Patient Immediate Molar Shaping Drill 6mmD, 6mmL |
| 00844868048114 | Single Patient Immediate Molar Shaping Drill 6mmD, 10mmL |
| 00844868048091 | Single Patient Immediate Molar Shaping Drill 5.4mmD, 8mmL |
| 00844868048077 | Single Patient Immediate Molar Shaping Drill 5.4mmD, 6mmL |
| 00844868048053 | Single Patient Immediate Molar Tapered Drill T3® PRO 5.1mmD |
| 00844868048039 | Single Patient Immediate Molar Shaping Drill 5.4mmD, 11.5mmL |
| 00844868048015 | Single Patient Immediate Molar Shaping Drill 5.4mmD, 10mmL |
| 00844868047995 | Single Patient Immediate Molar Tapered Drill TSX® 4.4mmD |