| Primary Device ID | D768TRIMAX870 |
| NIH Device Record Key | 04a1d6a3-b6fe-4cc7-b63b-36fe787852a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tri-Nex Implant System |
| Version Model Number | TRI-MAX8-7 |
| Catalog Number | TRI-MAX8-7 |
| Company DUNS | 787471015 |
| Company Name | KEYSTONE DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(781)328-3515 |
| cyoung@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D768TRIMAX870 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D768TRIMAX870]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-02-04 |
| D768TRIMAX990 | Implant |
| D768TRIMAX970 | Implant |
| D768TRIMAX9110 | Implant |
| D768TRIMAX890 | Implant |
| D768TRIMAX870 | Implant |
| D768TRIMAX8110 | Implant |
| D768TRIMAX790 | Implant |
| D768TRIMAX770 | Implant |
| D768TRIMAX7110 | Implant |
| D768IALH6080 | Implant |
| D768IALH60160 | Implant |
| D768IALH60130 | Implant |
| D768IALH601150 | Implant |
| D768IALH60100 | Implant |
| D768IALH5080 | Implant |
| D768IALH50160 | Implant |
| D768IALH50130 | Implant |
| D768IALH501150 | Implant |
| D768IALH50100 | Implant |
| D768IALH4380 | Implant |
| D768IALH43160 | Implant |
| D768IALH43130 | Implant |
| D768IALH431150 | Implant |
| D768IALH43100 | Implant |
| D768IALH3580 | Implant |
| D768IALH35160 | Implant |
| D768IALH35130 | Implant |
| D768IALH351150 | Implant |
| D768IALH35100 | Implant |
| D768IA5012D160 | Implant |
| D768IA5012D130 | Implant |
| D768IA5012D1150 | Implant |
| D768IA5012D100 | Implant |
| D768IA4312D160 | Implant |
| D768IA4312D130 | Implant |
| D768IA4312D1150 | Implant |
| D768IA4312D100 | Implant |