TPH Spectra® Universal Composite Restorative 642605
GUDID D0026426051
TPH Spectra® Universal Composite Restorative Low Viscosity Sample
DENTSPLY INTERNATIONAL INC.
Dental composite resin| Primary Device ID | D0026426051 |
| NIH Device Record Key | 24237031-2ea4-4b0f-8b66-aec7ac5c8388 |
| Commercial Distribution Discontinuation | 2024-05-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TPH Spectra® Universal Composite Restorative |
| Version Model Number | 642605 |
| Catalog Number | 642605 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 1 |
| 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 | 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)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
| Device Size Text, specify | 0 |
| Weight | 1 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026426051 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041343
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 | 2024-05-02 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [TPH Spectra® Universal Composite Restorative]
| D0026426061 | TPH Spectra® Universal Composite Restorative High Viscosity Sample |
| D0026426051 | TPH Spectra® Universal Composite Restorative Low Viscosity Sample |
Trademark Results [TPH Spectra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TPH SPECTRA 85935254 4411247 Live/Registered |
DENTSPLY International Inc. 2013-05-17 |
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