| Primary Device ID | D8130329122001 |
| NIH Device Record Key | 9c5dac66-9649-4cd5-ba39-cc2c2434b735 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duo:PCH® |
| Version Model Number | 032912200 |
| Catalog Number | 032912200 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 28 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130329122000 [Unit of Use] |
| HIBCC | D8130329122001 [Primary] |
| ELL | Teeth, Porcelain |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
[D8130329122001]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| D8130396225101 | DUO PCH CEMENT MULTI-SHADE 4pk |
| D8130396224101 | DUO PCH CEMENT OM1 2pk |
| D8130396223101 | DUO PCH CEMENT A3.5 2pk |
| D8130396222101 | DUO PCH CEMENT A2/B2 2pk |
| D8130396221101 | DUO PCH CEMENT A1/B1 2pk |
| D8130329131801 | DUO PCH LTRL XS 4pc #7&10 RFL |
| D8130329131701 | DUO PCH CSPD XS 4pc #6&11 RFL |
| D8130329131601 | DUO PCH CTRL XS 4pc #8&9RFL |
| D8130329131501 | DUO PCH CSPD S 4pc #6&11 RFL |
| D8130329131401 | DUO PCH LTRL S 4pc #7&10 RFL |
| D8130329131301 | DUO PCH CTRL S 4pc #8&9 RFL |
| D8130329131201 | DUO PCH CSPD M 4pc #6&11 RFL |
| D8130329131101 | DUO PCH LTRL M 4pc #7&10 RFL |
| D8130329131001 | DUO PCH CTRL M 4pc #8&9 RFL |
| D8130329130901 | DUO PCH CSPD L 4pc #6&11 RFL |
| D8130329130801 | DUO PCH LTRL L 4pc #7&10 RFL |
| D8130329130701 | DUO PCH CTRL L 4pc #8&9 RFL |
| D8130329130601 | DUO PCH CSPD XL 4pc #6&11 RFL |
| D8130329130501 | DUO PCH LTRL XL 4pc #7&10 RFL |
| D8130329130401 | DUO PCH CTRL XL 4pc #8&9 RFL |
| D8130329130301 | DUO PCH CSPD S 4pc #22&27 RFL |
| D8130329130201 | DUO PCH LTRL S 4pc #23&26 RFL |
| D8130329130101 | DUO PCH CTRL S 4pc #24&25 RFL |
| D8130329129901 | DUO PCH CSPD M 4pc #22&27 RFL |
| D8130329129801 | DUO PCH LTRL M 4pc #23&26 RFL |
| D8130329129701 | DUO PCH CTRL M 4pc #24&25 RFL |
| D8130329127701 | DUO PCH LWR UNIV BS M RFL |
| D8130329127001 | DUO PCH LWR UNIV BS S RFL |
| D8130329126301 | DUO PCH UPR UNIV BS XL RFL |
| D8130329125601 | DUO PCH UPR UNIV BS L RFL |
| D8130329124901 | DUO PCH UPR UNIV BS M RFL |
| D8130329124201 | DUO PCH UPR UNIV BS S RFL |
| D8130329123501 | DUO PCH UPR UNIV BICS XS RFL |
| D8130329122001 | DUO PCH 28 UNIT STARTER KIT |