| Primary Device ID | 07392532253140 | 
| NIH Device Record Key | 68d6cf45-4ece-42f6-8137-dba9197be4d4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MGUIDE® | 
| Version Model Number | MG-STN1 | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07392532253140 [Primary] | 
| NDP | Accessories, implant, dental, endosseous | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-04-12 | 
| Device Publish Date | 2024-04-04 | 
| 07392532253218 | MGUIDE - 8 implants | 
| 07392532253201 | MGUIDE - 7 implants | 
| 07392532253188 | MGUIDE - 5 implants | 
| 07392532253171 | MGUIDE - 4 implants | 
| 07392532253164 | MGUIDE - 3 implants | 
| 07392532253157 | MGUIDE - 2 implants | 
| 07392532253140 | MGUIDE - 1 implant | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MGUIDE  78550412  3110520 Dead/Cancelled | 80108 MEDIA, INC. 2005-01-19 |