Pain-Free™ S383
GUDID 10810000526960
Gel Application Tips (Pain-Free™ Gel, Etching Gel)
PARKELL, INC.
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 | 10810000526960 |
| NIH Device Record Key | 7d191f4a-f899-4ab8-b56a-018977256971 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pain-Free™ |
| Version Model Number | S383 |
| Catalog Number | S383 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 30 |
| DM Exempt | true |
| 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 | true |
| 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 | 00810000526963 [Unit of Use] |
| GS1 | 10810000526960 [Primary] |
FDA Product Code
| KLE | Agent, Tooth Bonding, Resin |
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 | 2022-06-03 |
| Device Publish Date | 2018-10-19 |
On-Brand Devices [Pain-Free™]
| M595S3860 | Pain-Free™-F Desensitizer with Fluoride |
| 10810000529619 | Pain-Free™ Gel Dentin Desensitizer |
| 10810000526960 | Gel Application Tips (Pain-Free™ Gel, Etching Gel) |
Trademark Results [Pain-Free]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAIN-FREE 78818463 not registered Dead/Abandoned |
Bruce, Jr., Robert G. 2006-02-19 |
 PAIN-FREE 73435197 1366058 Dead/Expired |
AFASSCO, INC. 1983-07-18 |
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