Predicta™ S621
GUDID 10810000527615
19-Guage Dispensing Tips for Predicta™ Materials (30 pcs)
PARKELL, INC.
Dental material mixing nozzle, non-sterile Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use Dental material injection cannula, single-use| Primary Device ID | 10810000527615 |
| NIH Device Record Key | 37edcafc-b622-4d6d-b71f-3090c468de45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Predicta™ |
| Version Model Number | S621 |
| Catalog Number | S621 |
| 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 | 00810000527618 [Unit of Use] |
| GS1 | 10810000527615 [Primary] |
FDA Product Code
| EBF | Material, Tooth Shade, 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 | 2019-04-15 |
| Device Publish Date | 2019-04-05 |
On-Brand Devices [Predicta™]
| 00810000525461 | Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Bulk Fill |
| 00810000525454 | Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Bulk Fill |
| 00810000525447 | Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Bulk Fill (LV) |
| 00810000525430 | Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Bulk Fill (LV) |
| 00810000525423 | Predicta™ Bioactive Core Dual-Cure Core Build-up Material Tooth Stackable |
| 00810000525416 | Predicta™ Bioactive Core Dual-Cure Core Build-up Material White Stackable |
| 00810000525409 | Predicta™ Bioactive Core Dual-Cure Core Build-up Material Tooth Flowable |
| 00810000525393 | Predicta™ Bioactive Core Dual-Cure Core Build-up Material White Flowable |
| 10810000527615 | 19-Guage Dispensing Tips for Predicta™ Materials (30 pcs) |
| 10810000527608 | 17-Guage Dispensing Tips for Predicta™ Materials (30 pcs) |
| 00810000527595 | 5ml Dispensing Gun for Predicta™ Materials |
| 10810000525529 | Predicta™ Bioactive Desensitizer Gel |
| 00810000525539 | Predicta™ Bioactive Desensitizer Gel 1-Syringe |
| 00810000525652 | Predicta™ Cement (Opaque) |
| 00810000525645 | Predicta™ Cement Universal (Shade A2) |
| 00810000525638 | Predicta™ Cement (Tranlucent) |
Trademark Results [Predicta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREDICTA 97712835 not registered Live/Pending |
Dairy Data Warehouse B.V. 2022-12-12 |
 PREDICTA 87456747 5829397 Live/Registered |
Parkell, Inc. 2017-05-19 |
 PREDICTA 86799632 5586574 Live/Registered |
PREDICTA, INC. 2015-10-26 |
 PREDICTA 80978455 0978455 Dead/Cancelled |
Kaufman and Broad Home Systems, Inc. 0000-00-00 |
 PREDICTA 78692381 not registered Dead/Abandoned |
Medtronic, Inc. 2005-08-15 |
 PREDICTA 76428708 2948883 Dead/Cancelled |
REVELL-MONOGRAM, LLC 2002-06-28 |
 PREDICTA 75370834 2336550 Live/Registered |
Riedel, David M. 1997-10-09 |
 PREDICTA 74443824 not registered Dead/Abandoned |
Predicta Systems, Inc. 1993-10-04 |
 PREDICTA 74408006 2040850 Dead/Cancelled |
Pipkins, Inc. 1993-06-29 |
 PREDICTA 74110126 1775695 Dead/Cancelled |
Genzyme Corporation 1990-10-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.