Implantswiss
- Primary DI
- 07630188202786
- Brand
- Implantswiss
- Company
- Novodent SA
- Model
- S-BFDLA
- Catalog number
- S-BFDLA
- Device description
- Bone Level Fixture Digital Lab-Analog
- Published
- 2021-04-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NDP | Accessories, Implant, Dental, Endosseous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 1 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K181266 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07630188202786 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07630188202786 | 07630188202786 | 7630188202786 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental implant suprastructure kit | A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 480055352
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07630188201857 | Implantswiss | S-TWSB | S-TWSB | 2021-03-31 |
| 07630188201864 | Implantswiss | S-TSB | S-TSB | 2021-03-31 |
| 07630188201871 | Implantswiss | S-PSB | S-PSB | 2021-03-31 |
| 07630188201888 | Implantswiss | S-PMSB | S-PMSB | 2021-03-31 |
| 07630188201895 | Implantswiss | S-PMUSB | S-PMUSB | 2021-03-31 |
| 07630188201901 | Implantswiss | S-POSB | S-POSB | 2021-03-31 |
| 07630188203028 | Implantswiss | S-TWFDLA | S-TWFDLA | 2021-03-31 |
| 07630188200461 | Implantswiss | S-T-RATCHET | S-T-RATCHET | 2021-04-30 |
| 07630188206739 | Implantswiss | S-BMUA48251 | S-BMUA48251 | 2021-08-12 |
| 07630188206746 | Impantswiss | S-BMUA48252 | S-BMUA48252 | 2021-08-12 |
| 07630188206753 | Implantswiss | S-BMUA48253 | S-BMUA48253 | 2021-08-12 |
| 07630188206869 | Implantswiss | S-BIPGP | s-BIPGP | 2021-08-12 |
| 07630188206876 | Implantswiss | S-BMUAICPGPin | S-BMUAICPGPin | 2021-08-12 |
| 07630188206883 | implantswiss | S-DP3.7 | S-DP3.7 | 2021-08-12 |
| 07630188206890 | Implantswiss | S-DP4.3 | S-DP4.3 | 2021-08-12 |
| 07640168190057 | Implantswiss | S-BMUA48251 | S-BMUA48251 | 2021-04-30 |
| 07640168190064 | Impantswiss | S-BMUA48252 | S-BMUA48252 | 2021-04-30 |
| 07640168190071 | Implantswiss | S-BMUAICPGPin | S-BMUAICPGPin | 2021-04-30 |
| 07640168190088 | Implantswiss | S-BIPGP | s-BIPGP | 2021-04-30 |
| 07640168190095 | Implantswiss | S-DP4.3 | S-DP4.3 | 2021-04-30 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07899995226457 | SLEEVE FOR SURGICAL GUIDEØ5.1MM OPEN | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226464 | SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPEN | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226471 | SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPEN | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226488 | SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPEN | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226495 | SLEEVE FOR SURGICAL GUIDE Ø5.1MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226501 | SLEEVE FOR SURGICAL GUIDE Ø5.1MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226518 | SLEEVE FOR SURGICAL GUIDE Ø3.9MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226525 | SLEEVE FOR SURGICAL GUIDE Ø3.9MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226532 | SLEEVE FOR FIXER GUIDE Ø2.0MM PALATAL | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226556 | SLEEVE FOR FIXER GUIDE Ø2.0MM PALATAL | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995226563 | SLEEVE FOR FIXER GUIDE Ø1.4MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234346 | DRIVER RATCHET IMP. MT16° GUIDED | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234353 | DRIVER RATCHET IMP. MT16° GUIDED NARROW | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234360 | DRIVER HANDP. IMP. MT16° GUIDED | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234377 | DRIVER HANDP. IMP. MT16° GUIDED NARROW | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234391 | ANALOG REVERSE MICRO MINI ABUT. | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234407 | ANALOG REVERSE MINI ABUT. | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234414 | ANALOG REVERSE CM11.5° | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234421 | ANALOG REVERSE MT16° | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234438 | ANALOG REVERSE ABUT MULT. | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234445 | ANALOG HYBRIDO ABUT UNIV Ø4.5X6MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234452 | ANALOG HYBRIDO ABUT UNIV Ø4.5X4MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234469 | ANALOG HYBRIDO ABUT UNIV Ø3.3X6MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234476 | ANALOG HYBRIDO ABUT UNIV Ø3.3X4MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234490 | ANALOG HYBRID MICRO MINI ABUT. | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234506 | ANALOG HYBRID 4.5IH | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234513 | ANALOG HYBRID 3.5IH | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234520 | ANALOG HYBRID 3.0IH | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234537 | ANALOG HYBRID HI Ø4.5MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |
| 07899995234544 | ANALOG HYBRID HI Ø3.8MM | Sin Sistema de Implante Nacional S/A | NDP | 2026-10-29 |