Pain-Free™ S382
GUDID 10810000529619
Pain-Free™ Gel Dentin Desensitizer
PARKELL, INC.
Dental coating, tooth-desensitizing, professional| Primary Device ID | 10810000529619 |
| NIH Device Record Key | 6377863c-dc1f-40f3-8823-1b3f3ee31de2 |
| Commercial Distribution Discontinuation | 2021-03-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Pain-Free™ |
| Version Model Number | S382 |
| Catalog Number | S382 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 3 |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product tightly sealed and away from direct sunlight. |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000529612 [Unit of Use] |
| GS1 | 10810000529619 [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 | 4 |
| Public Version Date | 2021-06-08 |
| 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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