Mach-2® S433S
GUDID 10810000524133
Mach-2® Die Silicone
PARKELL, INC.
Silicone dental impression material| Primary Device ID | 10810000524133 |
| NIH Device Record Key | 9ff2eb8f-e700-4e79-a380-1502b939446c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mach-2® |
| Version Model Number | S433 |
| Catalog Number | S433S |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 2 |
| 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
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Exposure to excessive heat will shorten shelf-life. For best results use at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000524136 [Unit of Use] |
| GS1 | 10810000524133 [Primary] |
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-01-25 |
| Device Publish Date | 2018-10-19 |
On-Brand Devices [Mach-2®]
| 00810000524129 | Starter Kit of Mach-2® Die Silicone |
| 10810000524119 | Base Former Trays for Mach-2® (Pkg. of 15 pcs.) |
| 10810000524133 | Mach-2® Die Silicone |
Trademark Results [Mach-2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACH-2 75245074 2134427 Live/Registered |
Parkell Inc. 1997-02-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.