DenQ Sub SLA Fixture I
- Primary DI
- 08800131001981
- Brand
- DenQ Sub SLA Fixture I
- Company
- DenQ Co.,Ltd.
- Model
- DSSW70120S
- Catalog number
- DSSW70120S
- Device description
- 6.8x12.0, Bone level
- Published
- 2026-03-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- 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 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K240977 | 000 | DenQ Sub SLA Implant System | Denq | 2024-09-13 | DZE |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800131001981 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800131001981 | 08800131001981 | 8800131001981 |
GMDN Terms
| Term | Definition |
|---|
| Basket 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 single, double, and/or triple contiguous cylinder(s) 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 1 Degrees Celsius | 30 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +82-7046473643 | s@denq.co.kr |
Regulatory Flags
- DUNS number
- 695155534
- 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
- true
- Expiration date on label
- true
- Donation ID number
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00880131035528 | DenQ Sub Cement Abutment | DSCR45504DS | DSCR45504DS | 2026-03-06 |
| 08800131035146 | DenQ Sub Cement Abutment | DSCR40104DS | DSCR40104DS | 2026-03-06 |
| 08800131035153 | DenQ Sub Cement Abutment | DSCR40154DS | DSCR40154DS | 2026-03-06 |
| 08800131035160 | DenQ Sub Cement Abutment | DSCR40204DS | DSCR40204DS | 2026-03-06 |
| 08800131035177 | DenQ Sub Cement Abutment | DSCR40254DS | DSCR40254DS | 2026-03-06 |
| 08800131035184 | DenQ Sub Cement Abutment | DSCR40304DS | DSCR40304DS | 2026-03-06 |
| 08800131035191 | DenQ Sub Cement Abutment | DSCR40354DS | DSCR40354DS | 2026-03-06 |
| 08800131035207 | DenQ Sub Cement Abutment | DSCR40404DS | DSCR40404DS | 2026-03-06 |
| 08800131035214 | DenQ Sub Cement Abutment | DSCR40454DS | DSCR40454DS | 2026-03-06 |
| 08800131035221 | DenQ Sub Cement Abutment | DSCR40504DS | DSCR40504DS | 2026-03-06 |
| 08800131035238 | DenQ Sub Cement Abutment | DSCR40055DS | DSCR40055DS | 2026-03-06 |
| 08800131035245 | DenQ Sub Cement Abutment | DSCR40105DS | DSCR40105DS | 2026-03-06 |
| 08800131035252 | DenQ Sub Cement Abutment | DSCR40155DS | DSCR40155DS | 2026-03-06 |
| 08800131035269 | DenQ Sub Cement Abutment | DSCR40205DS | DSCR40205DS | 2026-03-06 |
| 08800131035276 | DenQ Sub Cement Abutment | DSCR40255DS | DSCR40255DS | 2026-03-06 |
| 08800131035283 | DenQ Sub Cement Abutment | DSCR40305DS | DSCR40305DS | 2026-03-06 |
| 08800131035290 | DenQ Sub Cement Abutment | DSCR40355DS | DSCR40355DS | 2026-03-06 |
| 08800131035306 | DenQ Sub Cement Abutment | DSCR40405DS | DSCR40405DS | 2026-03-06 |
| 08800131035313 | DenQ Sub Cement Abutment | DSCR40455DS | DSCR40455DS | 2026-03-06 |
| 08800131035320 | DenQ Sub Cement Abutment | DSCR40505DS | DSCR40505DS | 2026-03-06 |
Other Devices Sharing Product Codes
denq.co.kr