INNO SLA Submerged Narrow Implant System-Multi S Abutment
- Primary DI
- 08800016100433
- Brand
- INNO SLA Submerged Narrow Implant System-Multi S Abutment
- Company
- Cowellmedi Co.,Ltd
- Model
- 2SMS454
- Published
- 2024-05-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K231395 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08800016100433 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 688753763
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
| 08800016115994 | Screw Kit | KIGICS001 | 2026-03-20 | |
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| 08800016176841 | Dental Instrument | KSRIG25R | 2026-01-29 | |
| 08800016176858 | Dental Instrument | KSRIG21N | 2026-01-29 | |
| 08800016176865 | Dental Instrument | KTW003 | 2026-01-29 | |
| 08800016101362 | Dental Instrument | KRMSD10S | 2026-01-28 | |
| 08800016114256 | Dental Implants Accesseories-Single Use | SSB100SN | 2026-01-28 | |
| 08800016114447 | Dental Instrument | KMTD18S | 2026-01-28 | |
| 08800016114454 | Dental Instrument | KMTD18L | 2026-01-28 | |
| 08800016114461 | Dental Instrument | KHTD1808 | 2026-01-28 | |
| 08800016114478 | Dental Instrument | KHTD1820 | 2026-01-28 | |
| 08800016114485 | Dental Instrument | KHTD1815 | 2026-01-28 | |
| 08800016115024 | Dental Instrument | KRBUD08 | 2026-01-28 | |
| 08800016115840 | Dental Instrument | KMATD18S | 2026-01-28 | |
| 08800016115857 | Dental Instrument | KMATD18L | 2026-01-28 | |
| 08800016116014 | Dental Instrument | KHSPLD01S | 2026-01-28 | |
| 08800016117769 | SFIT Crown Gauge | SFCG | 2026-01-28 | |
| 08800016117783 | Dental Implants Accesseories-Single Use | 2SSB100S | 2026-01-28 | |
| 08800016144772 | Dental Instrument | KHSPLD01L | 2026-01-28 | |
| 08800016146530 | Dental Implants Accesseories-Reusable | 2SMTN555 | 2026-01-28 |
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