| Primary Device ID | D768ABAMCZ50 |
| NIH Device Record Key | 5d6eee2b-a49c-4649-a0a1-4061cb523245 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ExHex |
| Version Model Number | ABAMCZ5 |
| Catalog Number | ABAMCZ5 |
| 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 | D768ABAMCZ50 [Primary] |
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D768ABAMCZ50]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-02-11 |
| D768TSUZ90 | Retention Screw |
| D768TSU90 | Retention Screw |
| D768TSU30 | Retention Screw |
| D768TSU20 | Retention Screw |
| D768TSU10 | Retention Screw |
| D768TSHZ30 | Retention Screw |
| D768TSHZ20 | Retention Screw |
| D768TSH30 | Retention Screw |
| D768TSH20 | Retention Screw |
| D768TSH10 | Retention Screw |
| D768SMAX9NH0 | Passive Abutment |
| D768SMAX9H0 | Passive Abutment |
| D768SBBB17TT0 | Passive Abutment |
| D768SBBB160 | Passive Abutment |
| D768SBA17TT0 | Passive Abutment |
| D768SBA160 | Passive Abutment |
| D768SB17TT0 | Passive Abutment |
| D768SB160 | Passive Abutment |
| D768GSUZ30 | Retention Screw |
| D768GSU90 | Retention Screw |
| D768GSU30 | Retention Screw |
| D768GSU20 | Retention Screw |
| D768GSU10 | Retention Screw |
| D768GSS90 | Retention Screw |
| D768GSQZ30 | Retention Screw |
| D768GSQZ20 | Retention Screw |
| D768GSQ30 | Retention Screw |
| D768GSQ20 | Retention Screw |
| D768GSIT20 | Retention Screw |
| D768GSH10 | Retention Screw |
| D768GMCW10 | Gold Sleeve |
| D768GMC10 | Gold Sleeve |
| D768GCNX700 | Gold Sleeve |
| D768GCNX600 | Gold Sleeve |
| D768GCNX500 | Gold Sleeve |
| D768GCNX400 | Gold Sleeve |
| D768GCNX340 | Gold Sleeve |
| D768GCEX700 | Gold Sleeve |
| D768GCEX600 | Gold Sleeve |
| D768GCEX500 | Gold Sleeve |
| D768GCEX400 | Gold Sleeve |
| D768GCEX340 | Gold Sleeve |
| D768EPCTN603KT0 | EPC Abutment |
| D768EPCTN602KT0 | EPC Abutment |
| D768EPCTN601KT0 | EPC Abutment |
| D768EPCTN503KT0 | EPC Abutment |
| D768EPCTN502KT0 | EPC Abutment |
| D768EPCTN501KT0 | EPC Abutment |
| D768EPCTN433KT0 | EPC Abutment |
| D768EPCTN432KT0 | EPC Abutment |