SmarTemp® S347
GUDID 10810000528124
SmarTemp® X1 10:1 50ml Mixing Tip Refill (30 pieces)
PARKELL, INC.
Dental material mixing nozzle, non-sterile| Primary Device ID | 10810000528124 |
| NIH Device Record Key | de3e644e-0cd6-4135-8538-5b5a2ae664e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmarTemp® |
| Version Model Number | S347 |
| Catalog Number | S347 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 30 |
| 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 | true |
| Lot Batch | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000528127 [Unit of Use] |
| GS1 | 10810000528124 [Primary] |
FDA Product Code
| EBG | Crown And Bridge, Temporary, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2019-09-27 |
On-Brand Devices [SmarTemp®]
| 00810000525317 | Medium A3.5 SmarTemp® in 50ml. Cartridge |
| 00810000525300 | Light A2 SmarTemp® in 50ml. Cartridge |
| 00810000525294 | Dual Cure A2 (Light Shade) SmarTemp® in 50ml. Cartridge |
| 00810000525287 | Ultralight A1 SmarTemp® Split 50ml. Cartridge |
| M595S3410 | Medium A3.5 SmarTemp® 50ml. Cartridge |
| M595S3400 | Light A2 SmarTemp® 50ml. Cartridge |
| M595S3380 | Dual Cure A2 (Light Shade) SmarTemp® 50ml. Cartridge |
| M595S3370 | Ultralight A1 SmarTemp® Split 50ml. Cartridge |
| 10810000528124 | SmarTemp® X1 10:1 50ml Mixing Tip Refill (30 pieces) |
| 00810000528134 | 10:1 50ml Split Cartridge Dispensing Gun for SmarTemp® X1 |
| 00810000525515 | SmarTemp® X1 Shade Bleach (50ml 10:1 Cartridge) |
| 00810000525508 | SmarTemp® X1 Shade B1 (50ml 10:1 Cartridge) |
| 00810000525492 | SmarTemp® X1 Shade A3 (50ml 10:1 Cartridge) |
| 00810000525485 | SmarTemp® X1 Shade A2 (50ml 10:1 Cartridge) |
| 00810000525478 | SmarTemp® X1 Shade A1 (50ml 10:1 Cartridge) |
| 10810000526953 | Mixing Tip with Blue Base for 50ml SmarTemp® (Pkg. of 30 pcs.) |
Trademark Results [SmarTemp]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.