Endo Access
- Primary DI
- D716XGATE0
- Brand
- Endo Access
- Company
- TULSA DENTAL PRODUCTS LLC
- Model
- XGATE
- Catalog number
- XGATE
- Device description
- Endo Access -X Gates
- Published
- 2022-10-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EJL | BUR, DENTAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EJL | Bur, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D716XGATE1 | Primary | HIBCC | 0 | |
| D716XGATE0 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Fixture/appliance dental drill bit, reusable | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 942778564
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D716PUENDO11 | ProUltra | PUENDO1 | PUENDO1 | 2016-10-07 |
| D716PUENDO151 | ProUltra | PUENDO1-5 | PUENDO1-5 | 2016-11-11 |
| D716PUENDO21 | ProUltra | PUENDO2 | PUENDO2 | 2016-10-07 |
| D716PUENDO31 | ProUltra | PUENDO3 | PUENDO3 | 2016-10-07 |
| D716PUENDO41 | ProUltra | PUENDO4 | PUENDO4 | 2016-10-07 |
| D716PUENDO51 | ProUltra | PUENDO5 | PUENDO5 | 2016-10-07 |
| D716PUENDO61 | ProUltra | PUENDO6 | PUENDO6 | 2016-10-07 |
| D716PUENDO681 | ProUltra | PUENDO6-8 | PUENDO6-8 | 2016-11-11 |
| D716PUENDO71 | ProUltra | PUENDO7 | PUENDO7 | 2016-10-07 |
| D716PUENDO81 | ProUltra | PUENDO8 | PUENDO8 | 2016-10-07 |
| D716PUSINE11 | ProUltra | PUSINE1 | PUSINE1 | 2016-10-07 |
| D716PUSINE161 | ProUltra SINE | PUSINE1-6 | PUSINE1-6 | 2016-11-11 |
| D716PUSINE21 | ProUltra | PUSINE2 | PUSINE2 | 2016-10-07 |
| D716PUSINE31 | ProUltra SINE | PUSINE3 | PUSINE3 | 2016-10-07 |
| D716PUSINE41 | ProUltra SINE | PUSINE4 | PUSINE4 | 2016-10-07 |
| D716PUSINE51 | ProUltra SINE | PUSINE5 | PUSINE5 | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE | PUSINE6 | PUSINE6 | 2016-10-07 |
| D716PUSURG11 | ProUltra | PUSURG1 | PUSURG1 | 2016-10-07 |
| D716PUSURG161 | ProUltra | PUSURG1-6 | PUSURG1-6 | 2016-11-11 |
| D716PUSURG21 | ProUltra | PUSURG2 | PUSURG2 | 2016-10-07 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00810126508270 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508294 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508300 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508317 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508324 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
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