| Primary Device ID | DIVO644386US0 |
| NIH Device Record Key | 0bd6a173-1747-4b37-93cc-f52a090e7bad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IPS e.max CAD AbutmentSolution |
| Version Model Number | 644386US |
| Catalog Number | 644386US |
| Company DUNS | 448015938 |
| Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
| Device Count | 5 |
| DM Exempt | false |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | DIVO644386US0 [Unit of Use] |
| HIBCC | DIVO644386US1 [Primary] |
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-18 |
| Device Publish Date | 2021-03-10 |
| DIVO644386US0 | IPS e.max CAD CER/inLab LT A3 A16 (L)/5 |
| DIVO644385US0 | IPS e.max CAD CER/inLab LT A2 A16 (L)/5 |
| 07615208583502 | IPS e.max CAD CER/inLab MO 0 A14 (S)/5 |
| 07615208583496 | IPS e.max CAD CER/inLab MO 1 A14 (S)/5 |
| 07615208583533 | IPS e.max CAD CER/inLab MO 2 A14 (S)/5 |
| 07615208583540 | IPS e.max CAD CER/inLab MO 3 A14 (S)/5 |
| 07615208583489 | IPS e.max CAD CER/inLab MO 4 A14 (S)/5 |
| 07615208583854 | IPS e.max CAD CER/inLab MO 0 A14 (L)/5 |
| 07615208583519 | IPS e.max CAD CER/inLab MO 1 A14 (L)/5 |
| 07615208583526 | IPS e.max CAD CER/inLab MO 2 A14 (L)/5 |
| 07615208583861 | IPS e.max CAD CER/inLab MO 3 A14 (L)/5 |
| 07615208583878 | IPS e.max CAD CER/inLab MO 4 A14 (L)/5 |
| 07615208583892 | IPS e.max CAD CER/inLab LT A1 A16 (S)/5 |
| 07615208583885 | IPS e.max CAD CER/inLab LT A2 A16 (S)/5 |
| 07615208583908 | IPS e.max CAD CER/inLab LT A3 A16 (S)/5 |
| 07615208583922 | IPS e.max CAD CER/inLab LT A3.5 A16(S)/5 |
| 07615208583977 | IPS e.max CAD CER/inLab LT B1 A16 (S)/5 |
| 07615208583960 | IPS e.max CAD CER/inLab LT B2 A16 (S)/5 |
| 07615208583953 | IPS e.max CAD CER/inLab LT C1 A16 (S)/5 |
| 07615208583939 | IPS e.max CAD CER/inLab LT C2 A16 (S)/5 |
| 07615208583915 | IPS e.max CAD CER/inLab LT D2 A16 (S)/5 |
| 07615208583946 | IPS e.max CAD CER/inLab LT A1 A16 (L)/5 |
| 07615208583984 | IPS e.max CAD CER/inLab LT A2 A16 (L)/5 |
| 07615208583991 | IPS e.max CAD CER/inLab LT A3 A16 (L)/5 |
| 07615208584004 | IPS e.max CAD CER/inLab LT A3.5 A16(L)/5 |
| 07615208584011 | IPS e.max CAD CER/inLab LT B1 A16 (L)/5 |
| 07615208584035 | IPS e.max CAD CER/inLab LT B2 A16 (L)/5 |
| 07615208584028 | IPS e.max CAD CER/inLab LT C1 A16 (L)/5 |
| 07615208584042 | IPS e.max CAD CER/inLab LT C2 A16 (L)/5 |
| 07615208584059 | IPS e.max CAD CER/inLab LT D2 A16 (L)/5 |
| 07615208584066 | IPS e.max CAD CER/inLab LT BL2 A16 (S)/5 |
| 07615208584073 | IPS e.max CAD CER/inLab LT BL2 A16 (L)/5 |
| 07615208584097 | IPS e.max CAD CER/inLab LT A1 A14 (S)/5 |
| 07615208584127 | IPS e.max CAD CER/inLab LT A2 A14 (S)/5 |
| 07615208584134 | IPS e.max CAD CER/inLab LT A3 A14 (S)/5 |
| 07615208584080 | IPS e.max CAD CER/inLab LT A3.5 A14(S)/5 |
| 07615208584103 | IPS e.max CAD CER/inLab LT B1 A14 (S)/5 |
| 07615208584110 | IPS e.max CAD CER/inLab LT B2 A14 (S)/5 |
| 07615208584141 | IPS e.max CAD CER/inLab LT C1 A14 (S)/5 |
| 07615208584172 | IPS e.max CAD CER/inLab LT C2 A14 (S)/5 |
| 07615208584158 | IPS e.max CAD CER/inLab LT D2 A14 (S)/5 |
| 07615208584189 | IPS e.max CAD CER/inLab LT A1 A14 (L)/5 |
| 07615208584196 | IPS e.max CAD CER/inLab LT A2 A14 (L)/5 |
| 07615208584165 | IPS e.max CAD CER/inLab LT A3 A14 (L)/5 |
| 07615208584202 | IPS e.max CAD CER/inLab LT A3.5 A14(L)/5 |
| 07615208584233 | IPS e.max CAD CER/inLab LT B1 A14 (L)/5 |
| 07615208584219 | IPS e.max CAD CER/inLab LT B2 A14 (L)/5 |
| 07615208584226 | IPS e.max CAD CER/inLab LT C1 A14 (L)/5 |
| 07615208584240 | IPS e.max CAD CER/inLab LT C2 A14 (L)/5 |
| 07615208584257 | IPS e.max CAD CER/inLab LT D2 A14 (L)/5 |