Identity
- Trade Name
- SIS EUDAMEDSurgical Kit FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Non-sterile dental surgical drill EUDAMEDThese Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely. FDA UDI
- Model / Reference
- SSD4013A EUDAMEDFDA UDI
- Description
- These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806343900555 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806343900555 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: General surgical procedure kit, non-medicated, single-use
Surgical Kit by Shinhung MST Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (2)
- FDA UDI f5687afd-754a-4c81-8e38-06cc8cce7a67 35 fields · synced Jun 19, 2026
- EUDAMED 7c942a4a-8c5c-47f4-a5e3-23744f23f056 61 fields · synced Jun 19, 2026