Triad® 95757
GUDID D001957570
Light Pink Fibered (Sheets)
Dentsply International Inc.
Dental appliance fabrication material, resin| Primary Device ID | D001957570 |
| NIH Device Record Key | fb59486a-c15d-4720-81f4-f1402631c90e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Triad® |
| Version Model Number | Original Flow Reline Material |
| Catalog Number | 95757 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
Device Dimensions
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
| Weight | 0.5 Kilogram |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D00180097018 [Unit of Use] |
| HIBCC | D001957570 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K834409
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2016-09-21 |
On-Brand Devices [Triad®]
| D00195768010 | Regular Pink Unfibered (Sheets) |
| D001957650 | VLC Bonding Agent |
| D001957580 | Regular Pink Fibered (Sheets) |
| D001957570 | Light Pink Fibered (Sheets) |
| D001957510 | Regular Pink Fibered (Sheets) |
| D001957500 | Light Pink Fibered (Sheets) |
| D00195745020 | Regular Pink Fibered (Sheets) |
| D00195745010 | Light Pink Fibered (Sheets) |
| D00195744020 | Regular Pink Fibered (Ropes) |
| D00195744010 | Light Pink Fibered (Ropes) |
| D00195743030 | Regular Pink Unfibered (Ropes) |
| D00195743020 | Regular Pink Fibered (Ropes) |
| D00195743010 | Light Pink Fibered (Ropes) |
| D00195742030 | Regular Pink Unfibered (Sheets) |
| D00195742020 | Regular Pink Fibered (Sheets) |
| D00195742010 | Light Pink Fibered (Sheets) |
| D0019055370 | DuaLine® Refill Package |
| D0019055300 | DuaLine® Introductory Package |
| D001901300 | Material Sample Kit |
| D001899350 | Dark Pink Fibered (Sheets) |
| D001897810 | Regular Pink Unfibered (Sheets) |
| D001897800 | Regular Pink Fibered (Sheets) |
| D001897790 | Light Pink Fibered (Sheets) |
| D001892760 | Pink (Sheets) |
| D001892750 | Colorless (Sheets) |
| D001892740 | Pink (Sheets) |
| D001892730 | Pink (Sheets) |
| D001892720 | Colorless (Sheets) |
| D001892710 | Colorless (Sheets) |
| D001892440 | Accessory Package |
| D001889780 | Regular Pink Fibered (Sheets) |
| D001889770 | Regular Pink Fibered (Sheets) |
| D001889750 | Light Pink Fibered (Sheets) |
| D001889261 | Light Pink Fibered (Sheets) |
| D001888600 | Gel Clear Pink |
| D001888590 | Gel Clear Colorless |
| D001887620 | Gel Assortment Package |
| D001887510 | Gel Clear Red |
| D001887500 | Gel Clear Blue |
Trademark Results [Triad]
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