MucoHard™ S486
GUDID 00810000525263
MucoHard™ Resin Refill Cartridge with Tips
PARKELL, INC.
Denture reliner, hard| Primary Device ID | 00810000525263 |
| NIH Device Record Key | 6391aaae-6714-4a61-afdb-5bf026405c40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MucoHard™ |
| Version Model Number | S486 |
| Catalog Number | S486 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 1 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a refrigerator with cap tightly screwed on. Avoid freezing. Allow material to come to room temp before use. Avoid storing near excessive heat, light or fresh eugenol-containing materials. |
| Storage Environment Temperature | Between 18 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000525263 [Primary] |
FDA Product Code
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2018-10-26 |
On-Brand Devices [MucoHard™]
| 00810000525270 | MucoHard™ Hard Denture Reline Kit |
| 00810000525263 | MucoHard™ Resin Refill Cartridge with Tips |
| 00810000525256 | MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes |
| M595S4870 | MucoHard™ Hard Denture Reline Kit |
| M595S4860 | MucoHard™ Resin Refill Cartridge with Tips |
| M595S4850 | MucoHard™ Bonding Liner with 6-Brushes & 6-Pipettes |
| 00810000525690 | MucoHard™+ Primer Refill |
| 00810000525683 | MucoHard™+ Cartridge Refill |
| 00810000525676 | MucoHard™+ Kit |
Trademark Results [MucoHard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUCOHARD 87217630 5214032 Live/Registered |
Parkell, Inc. 2016-10-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.