Thermafil TSLPLUS
GUDID D716TSLPLUS1
Sealer: Thermaseal Plus
TULSA DENTAL PRODUCTS LLC
Dental unfilled resin sealant/coating| Primary Device ID | D716TSLPLUS1 |
| NIH Device Record Key | 1a1a5df3-8da0-4e4f-b5f7-2e63dd2f53e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermafil |
| Version Model Number | TSLPLUS |
| Catalog Number | TSLPLUS |
| Company DUNS | 942778564 |
| Company Name | TULSA DENTAL PRODUCTS LLC |
| Device Count | 1 |
| 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 | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com |
Device Dimensions
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a Cool Dry Place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D716TSLPLUS1 [Primary] |
FDA Product Code
| KIF | RESIN, ROOT CANAL FILLING |
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 | 2024-11-04 |
| Device Publish Date | 2016-10-07 |
On-Brand Devices [Thermafil]
| D716SVK6401 | Verifier: PL 6pk 40/25mm |
| D716SVK6351 | Verifier: PL 6pk 35/25mm |
| D716SVK6301 | Verifier: PL 6pk 30/25mm |
| D716SVK6251 | Verifier: PL 6pk 25/25mm |
| D716SVK6201 | Verifier: PL 6pk 20/25mm |
| D716TSLPLUS1 | Sealer: Thermaseal Plus |
Trademark Results [Thermafil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMAFIL 73722550 1513500 Live/Registered |
TDP, INC. 1988-04-15 |
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