6 x 8mm Simpler Threaded Dental Implant
- Primary DI
- D780ST30210
- Brand
- 6 x 8mm Simpler Threaded Dental Implant
- Company
- Simpler Implant Solutions Inc
- Model
- ST 3021
- Catalog number
- ST 3021
- Device description
- 6mm x 8mm Simpler Threaded Grit Blasted Acid Etched coated dental implant
- Published
- 2015-11-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| DZE | Implant, Endosseous, Root-Form |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D780ST30210 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Screw endosteal dental implant, two-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis. |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 203213343
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- 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 |
|---|
| D780060376 | 6 x 13mm Simpler Threaded Dental Implant | ST 3023 | ST 3023 | 2015-11-13 |
| D78030220 | 6 x 10mm Simpler Threaded Dental Implant | ST 3022 | ST 3022 | 2015-11-13 |
| D780S0S33100 | 3.0mm x 10mm Maxi\Mini Dental Implant | SOS 3310 | SOS 3310 | 2015-10-24 |
| D780S0S5531 | Simpli MaxiMini HA Implants | S0S 5515 | S0S 5515 | 2015-10-24 |
| D780S0S56080 | 6 x 8mm Simpli MaxiMini HA Coated Dental Implants | S0S 5608 | S0S 5608 | 2015-11-13 |
| D780S150020 | 3.5 x 10 Simpler One Push in Implant HA | S1 5002 | S1 5002 | 2015-10-24 |
| D780S150030 | 3.25 x 13 Simpler One Push in Implant HA | S1 5003 | S1 5003 | 2015-10-24 |
| D780S150040 | 3.25mm x 15mm Simpler One Push in Implant HA | S1 5004 | S1 5004 | 2015-10-24 |
| D780S150050 | 4.0mm x 8mm Simpler One Push in Dental Implant HA | S1 5005 | S1 5005 | 2015-10-24 |
| D780S150060 | 4.0mm x 10mm Simpler One Push in Implant HA | S1 5006 | S1 5006 | 2015-10-24 |
| D780S150070 | 3.25mm x 13mm Simpler One Push in Implant HA | S1 5007 | S1 5007 | 2015-10-24 |
| D780S150080 | 4.0mm x 15mm Simpler One Push in Implant HA | S1 5008 | S1 5008 | 2015-10-24 |
| D780S1S33100 | 3 x 10mm Simpli Simpler One Piece Dental Implant | S1S 3310 | S1S 3310 | 2015-11-06 |
| D780S1S33130 | 3x13mm Simpli Simpler One Piece GBAE Dental Implant | S1S 3313 | S1S 3313 | 2015-11-06 |
| D780S1S33150 | 3 x 15mm Simpli Simpler One Piece GBAE Dental Implant | S1S 3315 | S1S 3315 | 2015-11-06 |
| D780S1S34080 | 4.0 x 8 Simpli Simpler One Piece GBAE Dental Implant | S1S 3408 | S1S 3408 | 2015-11-06 |
| D780S1S34100 | 4 x 10mm Simpli Simpler One Piece GBAE Dental Implant | S1S 3410 | S1S 3410 | 2015-11-06 |
| D780S1S34130 | 4 x 13 mm Simpli Simpler One Piece GBAE Dental Implant | S1S 3413 | S1S 3413 | 2015-11-06 |
| D780S1S34150 | 4.0 x 15mm Simpli Simpler One Piece GBAE Dental Implant | S1S 3415 | S1S 3415 | 2015-11-06 |
| D780S1S35080 | 5x8 Simpli Simpler One Piece GBAE Dental Implants | S1S 3508 | S1S 3508 | 2015-11-06 |
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