SQ Mini Guide Sleeve
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SQ Mini Guide Sleeve EUDAMEDFDA UDI
- Generic Name
- Dental implantation drilling template guide-sleeve FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / SQ Mini Guide Sleeve FDA UDIDental Implant Instrument / SQ Mini Guide Sleeve / DSQMGS4305 FDA UDI
- Model / Reference
- DSQMGS4307 EUDAMEDFDA UDIDSQMGS4305 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / SQ Mini Guide Sleeve FDA UDIDental Implant Instrument / SQ Mini Guide Sleeve / DSQMGS4305 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053069007 EUDAMEDFDA UDI08800053068994 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implantation drilling template guide-sleeve FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implantation drilling template guide-sleeve
SQ Mini Guide Sleeve by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (4)
- FDA UDI 63c85cbf-2bf6-4ce1-9035-798ef640a291 33 fields · synced Oct 8, 2026
- FDA UDI 6ddaaa8f-5585-47fc-9bf4-1d5de005227e 33 fields · synced May 30, 2026
- EUDAMED d46b54b5-6e49-4701-ae17-419da0359a64 61 fields · synced Jul 13, 2026
- EUDAMED 1362fb20-3ecc-4152-a802-bd8d8f981b36 61 fields · synced Oct 7, 2026