St

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref NSIR4510SFRef NSIR7007SFRef NSIR6011SRef NSIN3513SRef NSIR4007SRef STW5008SSFRef NSIR5010SRef STW5010SSRef NSIR6007SFRef NSIR5010SFRef NSIR7010SFRef NSIR5008SFRef NSIR6013SRef NSIR6008SFRef NSIR4015SRef NSIR4511SFRef NSIR4013SFRef NSIR4511SRef NSIR4515SRef NSIR5007SRef NSIR4507SFRef NSIR4507SRef NSIR7013SRef STW5011SSRef NSIR7011SRef STW5010SSFRef NSIR7013SFRef NSIR5008SRef NSIR4515SFRef NSIR4010SRef STW5008SSRef NSIR5015SRef NSIR7007SRef NSIR4510SRef NSIR5015SFRef STW5013SSFRef NSIR4011SRef NSIR6013SFRef NSIN3515SFRef NSIR6007SRef NSIN3510SRef NSIR7011SFRef NSIR4008SFRef NSIR4508SFRef NSIR5013SFRef NSIR6010SRef NSIN3511SRef NSIN3508S

by Shinhung MST Co., Ltd.

Identity

Trade Name: Luna S EUDAMED
ST FDA UDI
SI FDA UDI
Trial Kit - Luna S F40 FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name: Sterile dental implant system EUDAMED
Sterile dental implant system EUDAMED
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
Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI
Torque Wrench Square Adapter FDA UDI
Model / Reference: STW5008SS EUDAMEDFDA UDI
NSIR6008SF EUDAMEDFDA UDI
NSIR7013S EUDAMEDFDA UDI
NSIR4008SF EUDAMEDFDA UDI
NSIR7007S EUDAMEDFDA UDI
NSIR5013SF EUDAMEDFDA UDI
NSIR4508SF EUDAMEDFDA UDI
STW5010SSF EUDAMEDFDA UDI
NSIR7011S EUDAMEDFDA UDI
NSIR5007S EUDAMEDFDA UDI
NSIR6010S EUDAMEDFDA UDI
NSIR4510S EUDAMEDFDA UDI
NSIR4511SF EUDAMEDFDA UDI
NSIR6007S EUDAMEDFDA UDI
NSIR4013SF EUDAMEDFDA UDI
STW5011SS EUDAMEDFDA UDI
NSIR6013SF EUDAMEDFDA UDI
NSIR4010S EUDAMEDFDA UDI
NSIR4515S EUDAMEDFDA UDI
NSIN3508S EUDAMEDFDA UDI
NSIN3513S EUDAMEDFDA UDI
STW5010SS EUDAMEDFDA UDI
NSIN3511S EUDAMEDFDA UDI
NSIR4510SF EUDAMEDFDA UDI
NSIR6007SF EUDAMEDFDA UDI
NSIR4015S EUDAMEDFDA UDI
NSIR6011S EUDAMEDFDA UDI
NSIR7007SF EUDAMEDFDA UDI
NSIR7010SF EUDAMEDFDA UDI
NSIR5010S EUDAMEDFDA UDI
NSIR4507SF EUDAMEDFDA UDI
NSIR5015SF EUDAMEDFDA UDI
NSIN3510S EUDAMEDFDA UDI
NSIR4511S EUDAMEDFDA UDI
STW5013SSF EUDAMEDFDA UDI
NSIR7011SF EUDAMEDFDA UDI
NSIR7013SF EUDAMEDFDA UDI
NSIR4507S EUDAMEDFDA UDI
STW5008SSF EUDAMEDFDA UDI
NSIR4007S EUDAMEDFDA UDI
NSIR5008S EUDAMEDFDA UDI
NSIR5008SF EUDAMEDFDA UDI
NSIR4011S EUDAMEDFDA UDI
NSIR4515SF EUDAMEDFDA UDI
NSIR5015S EUDAMEDFDA UDI
NSIR6013S EUDAMEDFDA UDI
NSIN3515SF EUDAMEDFDA UDI
NSIR5010SF EUDAMEDFDA UDI
TWSA00 FDA UDI
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
Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction. FDA UDI
Torque Wrench Square Adapter FDA UDI

Identifiers

Primary DI / UDI-DI: 08809457204953 EUDAMEDFDA UDI
08809457201891 EUDAMEDFDA UDI
08809457201648 EUDAMEDFDA UDI
08809457201716 EUDAMEDFDA UDI
08809457201600 EUDAMEDFDA UDI
08809457201860 EUDAMEDFDA UDI
08809457201778 EUDAMEDFDA UDI
08809457205653 EUDAMEDFDA UDI
08809457201631 EUDAMEDFDA UDI
08809457201495 EUDAMEDFDA UDI
08809457201570 EUDAMEDFDA UDI
08809457201457 EUDAMEDFDA UDI
08809457201792 EUDAMEDFDA UDI
08809457201556 EUDAMEDFDA UDI
08809457201747 EUDAMEDFDA UDI
08809457204977 EUDAMEDFDA UDI
08809457201921 EUDAMEDFDA UDI
08809457201396 EUDAMEDFDA UDI
08809457201488 EUDAMEDFDA UDI
08809457201327 EUDAMEDFDA UDI
08809457201358 EUDAMEDFDA UDI
08809457204960 EUDAMEDFDA UDI
08809457201341 EUDAMEDFDA UDI
08809457201785 EUDAMEDFDA UDI
08809457201884 EUDAMEDFDA UDI
08809457201426 EUDAMEDFDA UDI
08809457201587 EUDAMEDFDA UDI
08809457201938 EUDAMEDFDA UDI
08809457201952 EUDAMEDFDA UDI
08809457201518 EUDAMEDFDA UDI
08809457201761 EUDAMEDFDA UDI
08809457201877 EUDAMEDFDA UDI
08809457201334 EUDAMEDFDA UDI
08809457201464 EUDAMEDFDA UDI
08809457205677 EUDAMEDFDA UDI
08809457201969 EUDAMEDFDA UDI
08809457201976 EUDAMEDFDA UDI
08809457201433 EUDAMEDFDA UDI
08809457205646 EUDAMEDFDA UDI
08809457201372 EUDAMEDFDA UDI
08809457201501 EUDAMEDFDA UDI
08809457201839 EUDAMEDFDA UDI
08809457201402 EUDAMEDFDA UDI
08809457201815 EUDAMEDFDA UDI
08809457201549 EUDAMEDFDA UDI
08809457201594 EUDAMEDFDA UDI
08809457201693 EUDAMEDFDA UDI
08809457201846 EUDAMEDFDA UDI
08806343920973 FDA UDI
Basic UDI-DI: B-08809457201785 EUDAMED
B-08809457201938 EUDAMED
B-08809457201587 EUDAMED
B-08809457201358 EUDAMED
B-08809457201372 EUDAMED
B-08809457205646 EUDAMED
B-08809457201518 EUDAMED
B-08809457204960 EUDAMED
B-08809457201884 EUDAMED
B-08809457201846 EUDAMED
B-08809457201952 EUDAMED
B-08809457201839 EUDAMED
B-08809457201594 EUDAMED
B-08809457201891 EUDAMED
B-08809457201426 EUDAMED
B-08809457201792 EUDAMED
B-08809457201747 EUDAMED
B-08809457201464 EUDAMED
B-08809457201488 EUDAMED
B-08809457201495 EUDAMED
B-08809457201761 EUDAMED
B-08809457201433 EUDAMED
B-08809457201648 EUDAMED
B-08809457204977 EUDAMED
B-08809457201631 EUDAMED
B-08809457205653 EUDAMED
B-08809457201976 EUDAMED
B-08809457201501 EUDAMED
B-08809457201815 EUDAMED
B-08809457201396 EUDAMED
B-08809457204953 EUDAMED
B-08809457201549 EUDAMED
B-08809457201600 EUDAMED
B-08809457201457 EUDAMED
B-08809457201877 EUDAMED
B-08809457205677 EUDAMED
B-08809457201402 EUDAMED
B-08809457201921 EUDAMED
B-08809457201693 EUDAMED
B-08809457201556 EUDAMED
B-08809457201334 EUDAMED
B-08809457201969 EUDAMED
B-08809457201716 EUDAMED
B-08809457201778 EUDAMED
B-08809457201860 EUDAMED
B-08809457201570 EUDAMED
B-08809457201341 EUDAMED
B-08809457201327 EUDAMED
510(k) Number: K221752 FDA UDI
K160106 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
EJB FDA UDI
EMDN Code: P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term: Screw endosteal dental implant, two-piece FDA UDI
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Class I FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
872.4565 FDA UDI
Market of Registration: Türkiye EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDIFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDIFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 8.5 Millimeter FDA UDI
Outer Diameter — 6.0 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI
Outer Diameter — 7.0 Millimeter FDA UDI
Outer Diameter — 4.2 Millimeter FDA UDI
Length — 7 Millimeter FDA UDI
Outer Diameter — 5.2 Millimeter FDA UDI
Outer Diameter — 4.7 Millimeter FDA UDI
Length — 11.5 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI
Outer Diameter — 3.7 Millimeter FDA UDI