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Quad™ Sectional Matrix Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref QR01Ref QR-KHF-11Ref Q-KHF-10Ref Q-KHF-00-RRef Q-KHF-40Ref Q-KHF-14Ref Q-KHF-00Ref Q-KH-00Ref Q-KHF-11Ref QR-KHF-14
Identity
- Trade Name
- Quad™ Sectional Matrix Kit EUDAMEDQuad Matrix System™ FDA UDI
- Generic Name
- Dental matrix band kit FDA UDIDental matrix band retainer FDA UDI
- Device Name
- Rings Family EUDAMEDBands Family EUDAMED1-Quad Sectional Matrix System Intro Kit FDA UDI1-Quad Rings Kit FDA UDI1-Quad Sectional Matrix System Refill Kit FDA UDI1-Quad Sectional Matrix System Standard Kit FDA UDI1-Quad Sectional Matrix System Professional Kit FDA UDI1-Quad Sectional Matrix System Deluxe Kit FDA UDI
- Model / Reference
- QR01 EUDAMEDFDA UDIQ-KHF-10 EUDAMEDFDA UDIQ-KHF-00 EUDAMEDFDA UDIQ-KHF-00-R EUDAMEDFDA UDIQ-KHF-40 EUDAMEDFDA UDIQ-KHF-11 EUDAMEDFDA UDIQR-KHF-14 EUDAMEDFDA UDIQR-KHF-11 EUDAMEDFDA UDIQ-KHF-14 EUDAMEDFDA UDIQ-KH-00 EUDAMED
- Description
- 1-Quad Sectional Matrix System Intro Kit FDA UDI1-Quad Rings Kit FDA UDI1-Quad Sectional Matrix System Refill Kit FDA UDI1-Quad Sectional Matrix System Standard Kit FDA UDI1-Quad Sectional Matrix System Professional Kit FDA UDI1-Quad Sectional Matrix System Deluxe Kit FDA UDI
Identifiers
- Catalog Number
- Q-KHF-10 FDA UDIQ-KHF-00 FDA UDIQR01 FDA UDIQ-KHF-00-R FDA UDIQ-KHF-40 FDA UDIQ-KHF-11 FDA UDIQR-KHF-14 FDA UDIQR-KHF-11 FDA UDIQ-KHF-14 FDA UDI
- Primary DI / UDI-DI
- 00810038091228 EUDAMEDFDA UDI00810038091419 EUDAMEDFDA UDI00810038091358 EUDAMEDFDA UDI00810038091440 EUDAMEDFDA UDI00810038091334 EUDAMEDFDA UDI00810038091365 EUDAMEDFDA UDI00810038091426 EUDAMEDFDA UDI00810038091402 EUDAMEDFDA UDI00810038091372 EUDAMEDFDA UDI00810038091495 EUDAMED
- Basic UDI-DI
- 081003809RingsTFCH EUDAMED081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMEDQ01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band kit FDA UDIDental matrix band retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDIEUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Moist Heat or Steam Sterilization FDA UDI
Quad™ Sectional Matrix Kit by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809RingsTFCH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (19)
- EUDAMED c03232cd-16e2-4d23-b98d-a380dcc8cc24 61 fields · synced Sep 18, 2026
- FDA UDI de02b71e-99da-42cf-bdba-f65c359ba799 35 fields · synced May 25, 2026
- FDA UDI 48543a8e-0151-447c-a9b0-0b976db510c2 35 fields · synced May 30, 2026
- FDA UDI 1f949c21-5e3c-43fa-9bf4-8da8c64c4661 35 fields · synced May 30, 2026
- FDA UDI 97935c01-4dcb-4f44-9abf-e159ee9ce76a 35 fields · synced May 30, 2026
- FDA UDI 174b0887-45d2-477e-adab-025e9a5dd313 35 fields · synced May 30, 2026
- FDA UDI b28d4cbb-2efa-4e42-b3aa-c7afc114ba43 35 fields · synced May 30, 2026
- FDA UDI 67371b90-0c87-4db5-8f2b-e5c2826a091c 35 fields · synced May 30, 2026
- FDA UDI 3682bc38-a605-482d-855c-656af8c42a04 35 fields · synced May 30, 2026
- FDA UDI 26ad6e02-3d2f-40d6-aa8f-87dd3b4bd1d8 35 fields · synced May 30, 2026
- EUDAMED e3423b35-0a61-4c83-934d-c7c201aa1620 61 fields · synced Jul 9, 2026
- EUDAMED 766df785-d3d4-42e3-beee-74c11788dc36 61 fields · synced Jul 14, 2026
- EUDAMED 79b94934-c0ff-4945-b331-52362d198916 61 fields · synced Jul 14, 2026
- EUDAMED 5a1cd9d8-53f5-4f23-8c1e-9ef278670262 61 fields · synced Jul 20, 2026
- EUDAMED 1ee2e50a-b5d1-4f8c-be94-484334c9dc2e 61 fields · synced Jul 20, 2026
- EUDAMED 7880f331-9a4c-4d36-ab74-742d292f959a 61 fields · synced Jul 24, 2026
- EUDAMED d69498ad-92ca-4e19-a358-0622007a65cd 61 fields · synced Aug 2, 2026
- EUDAMED 6ed34489-a36f-402b-87cd-7de2dd7add81 61 fields · synced Aug 3, 2026
- EUDAMED f363fca9-151b-4e49-a7d5-cadc24920433 61 fields · synced Sep 18, 2026