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Stella Dental Device
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
510(k) K221752Ref STR4507SSFRef STW5015SSRef STW4513LSRef STR4011LSFRef STGCAWBRef STR3513LSFRef STTPAW20CRef STR4015LSFRef STR4511SSFRef STTPAW10Ref STR4015LSRef STR4010SSRef STW4510LSFRef STW4513SSFRef STTPAR10Ref STW4510SSRef STR4015SSFRef STR4511SSRef STR3508SSRef STW4510SSFRef STR4515SSRef STR4508SSRef STR4515LSRef STR4515LSFRef STGCARSRef STR4013LSRef STW4515SSFRef STHAR20Ref STW4515SSRef STSPAW55Ref STR4510LSFRef STR4011SSFRef STESAW40Ref STW5015SSFRef STTPAR20CRef STESAW55Ref STW4507SSRef STR4513SSFRef STR4507SSRef STR3511SSFRef STR4510LSRef STR4513LSRef STR3511LSFRef STR4007SSFRef STR4508SSFRef STR4515SSFRef STSCAWRef STR3510SSFRef STR4013SSRef STW4508SSRef STR4015SSRef STW4513LSFRef STSPAW40Ref STR3510LSFRef STR4011LSRef STTPAR10CRef STW4515LSRef STR4008LSFRef STR3511LSRef STHAW40Ref STR4510SSRef STW4508LSFRef STR3515LSRef STR4008LSRef STR4010LSFRef STW5007SSFRef STR4008SSRef STR4513LSFRef STW4507LSFRef STW4515LSFRef STR4508LSFRef STTPAR20
Identity
- Trade Name
- Stella EUDAMEDST FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDIDental implant suprastructure, temporary, preformed, single-use FDA UDIDental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Sterile dental implant system EUDAMEDSterile & non-sterile dental implant system EUDAMEDThe Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture. FDA UDI
- Model / Reference
- STW4510SS EUDAMEDFDA UDISTW5015SS EUDAMEDFDA UDISTR4008LS EUDAMEDFDA UDISTR4513LSF EUDAMEDFDA UDISTR4511SSF EUDAMEDFDA UDISTHAR20 EUDAMEDFDA UDISTR3515LS EUDAMEDFDA UDISTTPAW10 EUDAMEDFDA UDISTR4515LSF EUDAMEDFDA UDISTR4508SS EUDAMEDFDA UDISTR4515SS EUDAMEDFDA UDISTR3508SS EUDAMEDFDA UDISTHAW40 EUDAMEDFDA UDISTR4515SSF EUDAMEDFDA UDISTW4510SSF EUDAMEDFDA UDISTR4511SS EUDAMEDFDA UDISTR3511LSF EUDAMEDFDA UDISTR3513LSF EUDAMEDFDA UDISTW4508LSF EUDAMEDFDA UDISTR4007SSF EUDAMEDFDA UDISTW4515SSF EUDAMEDFDA UDISTR4510LS EUDAMEDFDA UDISTR4513LS EUDAMEDFDA UDISTR4515LS EUDAMEDFDA UDISTR4507SS EUDAMEDFDA UDISTR4513SSF EUDAMEDFDA UDISTR4507SSF EUDAMEDFDA UDISTTPAR10C EUDAMEDFDA UDISTW4515LS EUDAMEDFDA UDISTR3510LSF EUDAMEDFDA UDISTSPAW55 EUDAMEDFDA UDISTW4510LSF EUDAMEDFDA UDISTR4010SS EUDAMEDFDA UDISTR4015LSF EUDAMEDFDA UDISTR4508LSF EUDAMEDFDA UDISTR4508SSF EUDAMEDFDA UDISTSPAW40 EUDAMEDFDA UDISTR3511SSF EUDAMEDFDA UDISTW5015SSF EUDAMEDFDA UDISTR4013LS EUDAMEDFDA UDISTTPAR10 EUDAMEDFDA UDISTR4008LSF EUDAMEDFDA UDISTW4507LSF EUDAMEDFDA UDISTR4011SSF EUDAMEDFDA UDISTR3511LS EUDAMEDFDA UDISTW4508SS EUDAMEDFDA UDISTW4513SSF EUDAMEDFDA UDISTR4013SS EUDAMEDFDA UDISTR4015SS EUDAMEDFDA UDISTR4510LSF EUDAMEDFDA UDISTR4011LS EUDAMEDFDA UDISTR4015LS EUDAMEDFDA UDISTW5007SSF EUDAMEDFDA UDISTW4513LS EUDAMEDFDA UDISTW4515SS EUDAMEDFDA UDISTW4515LSF EUDAMEDFDA UDISTR4011LSF EUDAMEDFDA UDISTW4507SS EUDAMEDFDA UDISTR3510SSF EUDAMEDFDA UDISTW4513LSF EUDAMEDFDA UDISTR4015SSF EUDAMEDFDA UDISTR4510SS EUDAMEDFDA UDISTR4008SS EUDAMEDFDA UDISTR4010LSF EUDAMEDFDA UDISTGCAWB EUDAMEDSTTPAW20C EUDAMEDSTGCARS EUDAMEDSTESAW40 EUDAMEDSTTPAR20C EUDAMEDSTESAW55 EUDAMEDSTSCAW EUDAMEDSTTPAR20 EUDAMED
- Description
- The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809457204878 EUDAMEDFDA UDI08809457204991 EUDAMEDFDA UDI08809457204601 EUDAMEDFDA UDI08809457205479 EUDAMEDFDA UDI08809457205462 EUDAMEDFDA UDI08809458315238 EUDAMEDFDA UDI08809457204564 EUDAMEDFDA UDI08809458315054 EUDAMEDFDA UDI08809457205493 EUDAMEDFDA UDI08809457204731 EUDAMEDFDA UDI08809457204816 EUDAMEDFDA UDI08809457204496 EUDAMEDFDA UDI08809458315283 EUDAMEDFDA UDI08809457205509 EUDAMEDFDA UDI08809457205561 EUDAMEDFDA UDI08809457204779 EUDAMEDFDA UDI08809457205219 EUDAMEDFDA UDI08809457205233 EUDAMEDFDA UDI08809457205530 EUDAMEDFDA UDI08809457205288 EUDAMEDFDA UDI08809457205622 EUDAMEDFDA UDI08809457204748 EUDAMEDFDA UDI08809457204786 EUDAMEDFDA UDI08809457204809 EUDAMEDFDA UDI08809457204717 EUDAMEDFDA UDI08809457205486 EUDAMEDFDA UDI08809457205400 EUDAMEDFDA UDI08809458315047 EUDAMEDFDA UDI08809457204922 EUDAMEDFDA UDI08809457205196 EUDAMEDFDA UDI08809458315405 EUDAMEDFDA UDI08809457205554 EUDAMEDFDA UDI08809457204632 EUDAMEDFDA UDI08809457205370 EUDAMEDFDA UDI08809457205417 EUDAMEDFDA UDI08809457205424 EUDAMEDFDA UDI08809458315399 EUDAMEDFDA UDI08809457205226 EUDAMEDFDA UDI08809457205684 EUDAMEDFDA UDI08809457204663 EUDAMEDFDA UDI08809458315030 EUDAMEDFDA UDI08809457205295 EUDAMEDFDA UDI08809457205516 EUDAMEDFDA UDI08809457205349 EUDAMEDFDA UDI08809457204526 EUDAMEDFDA UDI08809457204854 EUDAMEDFDA UDI08809457205608 EUDAMEDFDA UDI08809457204670 EUDAMEDFDA UDI08809457204694 EUDAMEDFDA UDI08809457205431 EUDAMEDFDA UDI08809457204649 EUDAMEDFDA UDI08809457204687 EUDAMEDFDA UDI08809457205639 EUDAMEDFDA UDI08809457204908 EUDAMEDFDA UDI08809457204939 EUDAMEDFDA UDI08809457205615 EUDAMEDFDA UDI08809457205332 EUDAMEDFDA UDI08809457204830 EUDAMEDFDA UDI08809457205202 EUDAMEDFDA UDI08809457205592 EUDAMEDFDA UDI08809457205387 EUDAMEDFDA UDI08809457204755 EUDAMEDFDA UDI08809457204618 EUDAMEDFDA UDI08809457205318 EUDAMEDFDA UDI08809458315016 EUDAMED08809458315108 EUDAMED08809458315009 EUDAMED08809458315450 EUDAMED08809458315085 EUDAMED08809458315467 EUDAMED08809458315351 EUDAMED08809458315078 EUDAMED
- Basic UDI-DI
- B-08809457205400 EUDAMEDB-08809457204991 EUDAMEDB-08809457204908 EUDAMEDB-08809457205332 EUDAMEDB-08809458315016 EUDAMEDB-08809457205233 EUDAMEDB-08809458315108 EUDAMEDB-08809457205370 EUDAMEDB-08809457205462 EUDAMEDB-08809458315054 EUDAMEDB-08809457204687 EUDAMEDB-08809457204632 EUDAMEDB-08809457205554 EUDAMEDB-08809457205608 EUDAMEDB-08809458315030 EUDAMEDB-08809457204878 EUDAMEDB-08809457205387 EUDAMEDB-08809457204779 EUDAMEDB-08809457204496 EUDAMEDB-08809457205561 EUDAMEDB-08809457204816 EUDAMEDB-08809457204731 EUDAMEDB-08809457204809 EUDAMEDB-08809457205493 EUDAMEDB-08809458315009 EUDAMEDB-08809457204663 EUDAMEDB-08809457205622 EUDAMEDB-08809458315238 EUDAMEDB-08809457204939 EUDAMEDB-08809458315405 EUDAMEDB-08809457205431 EUDAMEDB-08809457205349 EUDAMEDB-08809458315450 EUDAMEDB-08809457205684 EUDAMEDB-08809458315085 EUDAMEDB-08809458315467 EUDAMEDB-08809457204830 EUDAMEDB-08809457205486 EUDAMEDB-08809457204717 EUDAMEDB-08809457205226 EUDAMEDB-08809457204748 EUDAMEDB-08809457204786 EUDAMEDB-08809457205219 EUDAMEDB-08809457205288 EUDAMEDB-08809457205424 EUDAMEDB-08809457205509 EUDAMEDB-08809458315351 EUDAMEDB-08809457205202 EUDAMEDB-08809457204670 EUDAMEDB-08809457204854 EUDAMEDB-08809457204694 EUDAMEDB-08809457205592 EUDAMEDB-08809458315399 EUDAMEDB-08809457205196 EUDAMEDB-08809457204649 EUDAMEDB-08809458315047 EUDAMEDB-08809457204922 EUDAMEDB-08809457205295 EUDAMEDB-08809457204526 EUDAMEDB-08809458315283 EUDAMEDB-08809457204755 EUDAMEDB-08809457205530 EUDAMEDB-08809457204564 EUDAMEDB-08809457204601 EUDAMEDB-08809457205318 EUDAMEDB-08809457205639 EUDAMEDB-08809457204618 EUDAMEDB-08809457205479 EUDAMEDB-08809457205516 EUDAMEDB-08809457205615 EUDAMEDB-08809457205417 EUDAMEDB-08809458315078 EUDAMED
- 510(k) Number
- FDA Product Code
- DZE FDA 510(k)FDA UDINHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDIDental implant suprastructure, temporary, preformed, single-use FDA UDIDental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)FDA UDI872.3630 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
The Stella is a dental device classified under the Dental category, designed for use in oral healthcare procedures. It is intended for applications requiring precision and ergonomic handling, such as dental diagnostics or minor interventions in clinical settings.
Supplied as a reusable instrument, the Stella is intended for use in controlled environments such as dental clinics or offices. It adheres to FDA 510K and MDD regulatory standards, with a Traditional clearance pathway under the Dental advisory committee. The device is manufactured by Shinhung MST Co., Ltd., based in Wonju-Si, South Korea.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221752 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (137)
- FDA 510(k) K221752 24 fields · synced Sep 30, 2026
- FDA UDI e796b634-474d-4947-a73c-52629a460a87 35 fields · synced May 22, 2026
- FDA UDI 190d2376-3f55-4156-b9f9-09f77cd124f9 35 fields · synced May 24, 2026
- FDA UDI 90270181-f6d3-440a-a4f8-f0de2e0cce60 35 fields · synced May 24, 2026
- FDA UDI 4c4bcfc7-d5a1-4f9d-99ea-cf55c046584f 35 fields · synced May 25, 2026
- FDA UDI 1b97508c-f142-4a17-a5e7-7a128d95c52d 35 fields · synced May 25, 2026
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- FDA UDI 2b6cc940-84f7-4716-a470-1793781943b6 35 fields · synced May 29, 2026
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- FDA UDI 93e2a39b-04ae-4119-8780-76a5e08f00b5 35 fields · synced May 30, 2026
- EUDAMED 34579c78-572b-40dc-b424-bce2bbc164df 61 fields · synced Jun 20, 2026
- EUDAMED 199997f5-89cb-4c19-909d-1393a73d3ccf 61 fields · synced Jun 20, 2026
- EUDAMED 49cde528-8ad6-484c-91b2-947984ea3415 61 fields · synced Jun 20, 2026
- EUDAMED 7f54523e-6d7b-4929-af9d-1a0e20d95b2d 61 fields · synced Jul 8, 2026
- EUDAMED d337f3ee-1603-4766-90c1-2403c29d1247 61 fields · synced Jul 9, 2026
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- EUDAMED 70c56229-4cc2-4f37-9127-c293612f0e5f 61 fields · synced Jul 9, 2026
- EUDAMED 3082710b-769f-4b3e-a1d2-b47efbcb4cf2 61 fields · synced Jul 9, 2026
- EUDAMED c9d800c9-0a87-4bc1-9855-6202a7136bc4 61 fields · synced Jul 9, 2026
- EUDAMED 24902a6d-66b5-4ce3-af85-7d71a0938e94 61 fields · synced Jul 9, 2026
- EUDAMED 886d27c6-fd00-40ec-b2d1-59fc09976fc1 61 fields · synced Jul 10, 2026
- EUDAMED f8d9d999-287f-4ac7-ac5f-a1ffeea48faa 61 fields · synced Jul 10, 2026
- EUDAMED 060a1776-562e-4193-9779-57be97db5e2e 61 fields · synced Jul 11, 2026
- EUDAMED 93af0ec8-71ee-4515-8d6f-07c62eca89bc 61 fields · synced Jul 11, 2026
- EUDAMED d2699470-ef88-486f-936a-8ad0f9f0360a 61 fields · synced Jul 11, 2026
- EUDAMED 1599074d-3e8f-4639-8acd-f2d083fe809c 61 fields · synced Jul 11, 2026
- EUDAMED 59c2730c-b330-461f-978d-a55766345467 61 fields · synced Jul 11, 2026
- EUDAMED 1fb2201d-3000-4534-854d-ce9b5be81348 61 fields · synced Jul 11, 2026
- EUDAMED afbbdc1f-030c-42bc-8ced-b9eb0c1e2bf6 61 fields · synced Jul 12, 2026
- EUDAMED 712efc07-55fa-4126-8b92-14ac1a18a38d 61 fields · synced Jul 12, 2026
- EUDAMED 3868cfac-d447-4ed7-97e9-16c3f81e513e 61 fields · synced Jul 12, 2026
- EUDAMED 9ff62156-7bad-4691-9528-34f539d8c565 61 fields · synced Jul 13, 2026
- EUDAMED f6c1581a-ad24-4034-9a85-442ff9205456 61 fields · synced Jul 13, 2026
- EUDAMED 677fa555-59c2-45b6-bfc8-c6ac0f39a9f1 61 fields · synced Jul 14, 2026
- EUDAMED 20a95c39-70d4-40bb-8469-6615d11f89de 61 fields · synced Jul 14, 2026
- EUDAMED b255e574-788d-4c36-98bb-52a64dc3a0c4 61 fields · synced Jul 15, 2026
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