| Primary Device ID | D8963AS0 |
| NIH Device Record Key | 4a83850e-abed-49c3-bc1e-53fa53f29aaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | American Dental Implant |
| Version Model Number | 3AS |
| Catalog Number | 3AS |
| Company DUNS | 835556429 |
| Company Name | AMERICAN DENTAL IMPLANT CORPORATION |
| 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 | 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 | true |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com | |
| Phone | 8005110661 |
| info@americandentalimplant.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8963AS0 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
[D8963AS0]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-19 |
| Device Publish Date | 2018-07-31 |
| D896WDCS0 | 4.5mm First Stage Surgical Cover Screw (.050 Hex Drive) |
| D896TH5765050 | 5.7/6.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck |
| D896TH5765030 | 5.7/6.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck |
| D896TH4555050 | 4.5/5.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck |
| D896TH4555030 | 4.5/5.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck |
| D896TH45050 | 4.5mm Tissue Healing Abutment 5mm Neck |
| D896TH45030 | 4.5mm Tissue Healing Abutment 3mm Neck |
| D896TH3545050 | 3.5/4.5mm Flared Emergence Profile Tissue Healing Abutment 5mm Neck |
| D896TH3545030 | 3.5/4.5mm Flared Emergence Profile Tissue Healing Abutment 3mm Neck |
| D896TH35050 | 3.5mm Tissue Healing Abutment 5mm Neck |
| D896TH35030 | 3.5mm Tissue Healing Abutment 3mm Neck |
| D896TH30050 | 3.0mm Tissue Healing Abutment 5mm Neck |
| D896TH30030 | 3.0mm Tissue Healing Abutment 3mm Neck |
| D896TH30020 | 3.0mm Tissue Healing Abutment 2mm Neck |
| D896TD600 | 6mm Trephine Drill |
| D896TD500 | 5mm Trephine Drill |
| D896TD400 | 4mm Trephine Drill |
| D896T6016RBM0 | 6.0mm x 16mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T6016HA0 | 6.0mm x 16mm XL Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T6013RBM0 | 6.0mm x 13mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T6013HA0 | 6.0mm x 13mm XL Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T60115RBM0 | 6.0mm x 11.5mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T60115HA0 | 6.0mm x 11.5mm XL Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T6010RBM0 | 6.0mm x 10mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T6010HA0 | 6.0mm x 10mm XL Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T6008RBM0 | 6.0mm x 08mm XL Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T6008HA0 | 6.0mm x 08mm XL Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T4716RBM0 | 4.7mm x 16mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T4716HA0 | 4.7mm x 16mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T4713RBM0 | 4.7mm x 13mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T4713HA0 | 4.7mm x 13mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T47115RBM0 | 4.7mm x 11.5mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T47115HA0 | 4.7mm x 11.5mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T4710RBM0 | 4.7mm x 10mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T4710HA0 | 4.7mm x 10mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T4708RBM0 | 4.7mm x 08mm Wide Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T4708HA0 | 4.7mm x 08mm Wide Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T3716RBM0 | 3.7mm x 16mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T3716HA0 | 3.7mm x 16mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T3713RBM0 | 3.7mm x 13mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T3713HA0 | 3.7mm x 13mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T37115RBM0 | 3.7mm x 11.5mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T37115HA0 | 3.7mm x 11.5mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T3710RBM0 | 3.7mm x 10mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T3710HA0 | 3.7mm x 10mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T3708RBM0 | 3.7mm x 08mm Standard Diameter Tapered Internal Hex Dental Implant RBM Surface |
| D896T3708HA0 | 3.7mm x 08mm Standard Diameter Tapered Internal Hex Dental Implant HA Surface |
| D896T3216RBM0 | 3.2mm x 16mm Tapered Internal Hex Dental Implant RBM Surface |
| D896T3216HA0 | 3.2mm x 16mm Tapered Internal Hex Dental Implant HA Surface |
| D896T3213RBM0 | 3.2mm x 13mm Tapered Internal Hex Dental Implant RBM Surface |