Peak SE 5135
GUDID 00883205104311
Peak SE Primer Refill
ULTRADENT PRODUCTS, INC.
Dentine adhesive| Primary Device ID | 00883205104311 |
| NIH Device Record Key | ec7bc548-a9bc-4013-bb8d-83dcf79ea69d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peak SE |
| Version Model Number | 5135 |
| Catalog Number | 5135 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| 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(801)572-4200 |
| customerservice@ultradent.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205104311 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063558
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 | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
Devices Manufactured by ULTRADENT PRODUCTS, INC.
| 00883205030177 - White Mac Tip | 2024-12-25 White Mac Tips 10pk |
| 00883205030900 - VALO | 2024-12-25 VALO GRAND SAPPHIRE (Cordless) |
| 00883205030917 - VALO | 2024-12-25 VALO GRAND RED ROCK (CORDLESS) |
| 00883205030924 - VALO | 2024-12-25 VALO GRAND MIDNIGHT (CORDLESS) |
| 00883205031587 - Thermo Clone VPS | 2024-12-25 Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit |
| 00883205031709 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack |
| 00883205031716 - Thermo Clone | 2024-12-25 Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack |
| 00883205031860 - Gishy Goo | 2024-12-25 Gishy Goo! One-Patient Kit Tooth Color |
Trademark Results [Peak SE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEAK SE 77053558 3669742 Live/Registered |
Ultradent Products, Inc. 2006-11-29 |
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