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Composi-Tight® 3D Fusion™ Sectional Matrix Kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FXR01Ref FX-KFF-40Ref FX-HHF-40Ref FX-KFF-14Ref FXR-KFF-10Ref FX-KFF-11Ref FX-MFF-00Ref FXR-KFF-14Ref FX-KFF-04Ref FX-KFF-50Ref FXR-HHF-10Ref FXR-KFF-11Ref https://www.garrisondental.com/Instructions-For-Use-HubRef FX-KFF-35

by Garrison Dental Solutions LLC

Identity

Trade Name
Composi-Tight® 3D Fusion™ Sectional Matrix Kit EUDAMED
Composi-Tight® FDA UDI
Generic Name
Dental matrix band kit FDA UDI
Dental matrix band retainer FDA UDI
Device Name
Rings Family EUDAMED
Bands Family EUDAMED
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) Short Ring, (1) Tall Ring, (1) Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Sectional Matrix System (Trial Kit): (25) Full Curve Matrices, (20) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (12) FenderWedge®, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps, (1) Multi-Function Instrument FDA UDI
3D Fusion™ Sectional Matrix System: (40) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps, (1) Multi-Function Instrument FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Matrix System: (40) Firm Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (12) FenderWedge®, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (50) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Matrix System: (70) Firm Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (20) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (40) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX600 Wide Prep Ring FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Ring Kit: 3 Count (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring FDA UDI
Model / Reference
FXR01 EUDAMEDFDA UDI
FXR-KFF-14 EUDAMEDFDA UDI
FX-MFF-00 EUDAMEDFDA UDI
FX-KFF-11 EUDAMEDFDA UDI
FX-KFF-40 EUDAMEDFDA UDI
FXR-KFF-11 EUDAMEDFDA UDI
FX-KFF-04 EUDAMEDFDA UDI
FX-HHF-40 EUDAMEDFDA UDI
FX-KFF-14 EUDAMEDFDA UDI
FXR-HHF-10 EUDAMEDFDA UDI
FX-KFF-35 EUDAMEDFDA UDI
FX-KFF-50 EUDAMEDFDA UDI
FXR-KFF-10 EUDAMEDFDA UDI
https://www.garrisondental.com/Instructions-For-Use-Hub EUDAMED
FX-MFF-10 FDA UDI
Description
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) Short Ring, (1) Tall Ring, (1) Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Sectional Matrix System (Trial Kit): (25) Full Curve Matrices, (20) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (12) FenderWedge®, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps, (1) Multi-Function Instrument FDA UDI
3D Fusion™ Sectional Matrix System: (40) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps, (1) Multi-Function Instrument FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Matrix System: (40) Firm Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (12) FenderWedge®, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (50) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
3D Fusion™ Matrix System: (70) Firm Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (20) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Sectional Matrix System: (40) Full Curve Matrices, (40) Wedges, (1) FX400 Short Ring, (1) FX600 Wide Prep Ring FDA UDI
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps FDA UDI
3D Fusion™ Ring Kit: 3 Count (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring FDA UDI

Identifiers

Catalog Number
FXR-KFF-14 FDA UDI
FX-MFF-00 FDA UDI
FX-KFF-11 FDA UDI
FX-KFF-40 FDA UDI
FXR-KFF-11 FDA UDI
FX-KFF-04 FDA UDI
FX-HHF-40 FDA UDI
FX-MFF-10 FDA UDI
FX-KFF-14 FDA UDI
FXR-HHF-10 FDA UDI
FX-KFF-35 FDA UDI
FX-KFF-50 FDA UDI
FXR-KFF-10 FDA UDI
FXR01 FDA UDI
Primary DI / UDI-DI
00810038095608 EUDAMEDFDA UDI
00810038095646 EUDAMEDFDA UDI
00810038095585 EUDAMEDFDA UDI
00810038095486 EUDAMEDFDA UDI
00810038095523 EUDAMEDFDA UDI
00810038095639 EUDAMEDFDA UDI
00810038095462 EUDAMEDFDA UDI
00810038095417 EUDAMEDFDA UDI
00810038095592 EUDAMEDFDA UDI
00810038095493 EUDAMEDFDA UDI
00810038095615 EUDAMEDFDA UDI
00810038095509 EUDAMEDFDA UDI
00810038095547 EUDAMEDFDA UDI
00810038095622 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
Dental 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 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® 3D Fusion™ Sectional Matrix 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 (28)

  • EUDAMED 24d4b69f-893a-41ca-8643-2395f00a897e 61 fields · synced Aug 4, 2026
  • FDA UDI 149b874f-ffc0-49ce-a958-5e649434a569 35 fields · synced May 29, 2026
  • FDA UDI 2f0f4fb5-efc3-42e7-aba5-ea896063a851 35 fields · synced May 30, 2026
  • FDA UDI a4dcd971-4ef4-4ea7-87c3-afcc12220716 35 fields · synced May 30, 2026
  • FDA UDI 5c6a6010-619f-4258-b199-a25ca53ca291 35 fields · synced May 30, 2026
  • FDA UDI 0353c0e1-727a-4a84-96a8-2696ebfdf745 35 fields · synced May 30, 2026
  • FDA UDI 86407e02-f203-4174-83b1-f8d814260bdb 35 fields · synced May 30, 2026
  • FDA UDI 6b57fe3e-b1fa-4ee8-a238-0840411da394 35 fields · synced May 30, 2026
  • FDA UDI 1567c2fd-b243-45a1-8a4c-c207f708e5cb 35 fields · synced May 30, 2026
  • FDA UDI 89ef1612-7e5e-41d2-a661-4881b31077dc 35 fields · synced May 30, 2026
  • FDA UDI 97f7c9d2-4dff-4a82-b3e2-24d861f5ee63 35 fields · synced May 30, 2026
  • FDA UDI 8d7c3734-c167-4a9a-b1db-03b6e3969524 35 fields · synced May 30, 2026
  • FDA UDI ef24710e-7086-4876-94eb-d73983025e97 35 fields · synced May 30, 2026
  • FDA UDI cb6ca70d-0df8-42a4-b049-418cec0a8e74 35 fields · synced May 30, 2026
  • FDA UDI 9f56cbce-5785-41da-b920-fb7e6f960b4e 35 fields · synced May 30, 2026
  • EUDAMED a6aa6b7c-2642-4729-b7ec-416f45be7baf 61 fields · synced Jun 20, 2026
  • EUDAMED a6bc7029-9a3c-4fe0-ad61-407072752222 61 fields · synced Jul 9, 2026
  • EUDAMED 849e8afc-55d0-4223-9e16-a3b541df9fe6 61 fields · synced Jul 11, 2026
  • EUDAMED 81b8e797-b4f9-4d8e-a215-de3f938e0de8 61 fields · synced Jul 15, 2026
  • EUDAMED f409e004-5a8d-4ad5-9661-ccfcf943db72 61 fields · synced Jul 15, 2026
  • EUDAMED aec7842e-8799-4e94-b906-8829b256a15c 61 fields · synced Jul 17, 2026
  • EUDAMED 564c6670-d826-49a0-b61f-d5b343e22f78 61 fields · synced Jul 17, 2026
  • EUDAMED ed618a5a-15e8-4e3f-92d3-5f7b018560c8 61 fields · synced Jul 18, 2026
  • EUDAMED a09de2c3-02e9-42bf-9505-0cc5139b45f2 61 fields · synced Jul 20, 2026
  • EUDAMED 22e2e318-e87a-4522-bd7e-aa11c2b821a9 61 fields · synced Jul 21, 2026
  • EUDAMED f245ff6e-eab2-4a91-91b1-f78e4f2c828d 61 fields · synced Jul 27, 2026
  • EUDAMED 1f180d0a-640b-44f8-87d3-34e70b4e6fed 61 fields · synced Aug 1, 2026
  • EUDAMED 6c0e483d-f116-4cf2-b6f6-303a59efbc04 61 fields · synced Aug 4, 2026