SIMPLANT®
GUDID 07392532185229
Extra Custom Guide
DENTSPLY IH, INC.
Surgical drill guide, single-use, sterile| Primary Device ID | 07392532185229 |
| NIH Device Record Key | d4cc99f1-55ba-48c9-a2e1-e3d5cd2a50c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLANT® |
| Version Model Number | 54500226 |
| Company DUNS | 847337201 |
| Company Name | DENTSPLY IH, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, do not expose to UV-light and moisture |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07392532185229 [Primary] |
FDA Product Code
| NDP | Accessories, implant, dental, endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
[07392532185229]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-09-30 |
On-Brand Devices [SIMPLANT®]
| 07392532185236 | Other Custom Guide |
| 07392532185229 | Extra Custom Guide |
| 07392532177064 | SIMPLANT Guide |
Trademark Results [SIMPLANT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLANT 79016792 3171725 Live/Registered |
DENTSPLY Implants NV 2004-10-27 |
 SIMPLANT 77848515 3877954 Dead/Cancelled |
WomanCare Global LLC 2009-10-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.