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Composi-Tight® 3DXR Sectional Matrix System Kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 3D-KSA-10Ref 3D-KSA-00Ref 3D-KSW-35Ref 3D-KFF-10Ref 3D-KFF-00Ref 3D-KSA-11Ref K102

by Garrison Dental Solutions LLC

Identity

Trade Name
Composi-Tight® 3DXR Sectional Matrix System Kit EUDAMED
Composi-Tight® Matrix System Kit EUDAMED
Composi-Tight® FDA UDI
Generic Name
Dental matrix band kit FDA UDI
Device Name
Rings Family EUDAMED
Bands Family EUDAMED
3DXR Sectional Matrix Kit: (100) 3D Fusion™ Full Curve Matrices, (100) 3D Fusion™ Wedges, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Sectional Matrix Kit: (40) Slick Bands™ XR Matrices, (20) WedgeWands®, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
Original Sectional Matrix Kit: (225) Matrices, (4) G100 G-Rings, (3) G200 G-Rings, (1) Ring Placement Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (20) FenderWedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (20) FenderWedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) 3D Fusion™ Wedges, (20) FenderWedge®, (2) 3D500 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
Model / Reference
3D-KSA-10 EUDAMEDFDA UDI
3D-KSA-00 EUDAMEDFDA UDI
3D-KSW-35 EUDAMEDFDA UDI
3D-KFF-10 EUDAMEDFDA UDI
3D-KFF-00 EUDAMEDFDA UDI
3D-KSA-11 EUDAMEDFDA UDI
K102 EUDAMEDFDA UDI
Description
3DXR Sectional Matrix Kit: (100) 3D Fusion™ Full Curve Matrices, (100) 3D Fusion™ Wedges, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Sectional Matrix Kit: (40) Slick Bands™ XR Matrices, (20) WedgeWands®, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
Original Sectional Matrix Kit: (225) Matrices, (4) G100 G-Rings, (3) G200 G-Rings, (1) Ring Placement Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (20) FenderWedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3DXR Complete Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) A+Wedge®, (20) FenderWedge®, (2) 3D600 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI
3DXR Sectional Matrix Kit: (100) Slick Bands™ XR Matrices, (100) 3D Fusion™ Wedges, (20) FenderWedge®, (2) 3D500 Rings, (1) 3DXR Ring, (1) Gold Handle Ring Placement Forceps FDA UDI

Identifiers

Catalog Number
3D-KFF-00 FDA UDI
3D-KSW-35 FDA UDI
K102 FDA UDI
3D-KSA-00 FDA UDI
3D-KSA-11 FDA UDI
3D-KSA-10 FDA UDI
3D-KFF-10 FDA UDI
Primary DI / UDI-DI
00810038094960 EUDAMEDFDA UDI
00810038094953 EUDAMEDFDA UDI
00810038095066 EUDAMEDFDA UDI
00810038094939 EUDAMEDFDA UDI
00810038094922 EUDAMEDFDA UDI
00810038094977 EUDAMEDFDA UDI
00810038095738 EUDAMEDFDA UDI
Basic UDI-DI
081003809RingsTFCH EUDAMED
081003809BandsTFXZ EUDAMED
FDA Product Code
JEP FDA UDI
EMDN Code
Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term
Dental matrix band kit 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 UDI

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Composi-Tight® 3DXR Sectional Matrix System Kit by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Garrison Dental Solutions LLC
EUDAMED SRN
US-MF-000004112
Authorised Representative
Eurolink Europe Compliance Limited IE-AR-000002852

Sources (20)

  • EUDAMED 07a90b21-3695-4b97-824b-2a2b6e1d7c41 61 fields · synced Aug 2, 2026
  • EUDAMED 5200084a-2253-41fd-9d25-1d19ee15ae87 61 fields · synced May 16, 2026
  • EUDAMED e2eb0bbd-e63c-4c04-85e1-f39c8fcda476 61 fields · synced May 16, 2026
  • EUDAMED a1f21ca9-c3c1-47bf-ada3-7c42a6e77873 61 fields · synced May 17, 2026
  • EUDAMED 74977d10-81cd-4020-b58b-e16674272b28 61 fields · synced May 18, 2026
  • EUDAMED 135cfdea-6e7c-482d-bfc3-2a405790a2c6 61 fields · synced May 19, 2026
  • FDA UDI 825cc619-9094-4b17-ac80-1e5fcb80bc5f 35 fields · synced May 29, 2026
  • FDA UDI 24aef5ad-c555-45fc-a4b6-43abc34c24b5 35 fields · synced May 30, 2026
  • FDA UDI 8c8aa671-f7ca-4788-936c-95d24f2059c3 35 fields · synced May 30, 2026
  • FDA UDI 669c5c78-e5dd-40b1-9732-82f7da02a8ae 35 fields · synced May 30, 2026
  • FDA UDI 41b79770-4c85-4451-9564-9e1baab6b6d9 35 fields · synced May 30, 2026
  • FDA UDI 0335d170-d160-47be-952b-cdb6ee03c048 35 fields · synced May 30, 2026
  • FDA UDI 63c382e2-63d4-4f53-b005-0618622ae9ab 35 fields · synced May 30, 2026
  • EUDAMED 3bcf0aa3-e346-4e7e-8649-9ac43ebdf647 61 fields · synced Jul 11, 2026
  • EUDAMED 056c709c-fcf1-42ae-8b0c-63293f828d94 61 fields · synced Jul 12, 2026
  • EUDAMED 4249f12a-ea04-4cc2-a477-fa08c36fd546 61 fields · synced Jul 15, 2026
  • EUDAMED 92c759da-d354-45e9-bdad-62bffe9c0ca6 61 fields · synced Jul 21, 2026
  • EUDAMED 92123295-cf8a-48c0-ac5a-e0f7f09ba170 61 fields · synced Jul 24, 2026
  • EUDAMED 6022dcb4-254c-4a14-96a6-8e34e29e0ad1 61 fields · synced Jul 29, 2026
  • EUDAMED e2a06ccd-e5ce-472d-aaf1-8361a98d3a24 61 fields · synced Aug 2, 2026