StatStix

FDA UDI

Class U (US FDA UDI)

by Centrix, Inc.

Identity

Trade Name: StatStix FDA UDI
Generic Name: Gingival retraction cord, non-medicated FDA UDI
Device Name: StatStix Black Regular FDA UDI
Model / Reference: 380065 FDA UDI
Description: StatStix Black Regular FDA UDI

Identifiers

Primary DI / UDI-DI: 00817051022970 FDA UDI
510(k) Number: K200764 FDA UDI
FDA Product Code: MVL FDA UDI
EJB FDA UDI
GMDN Term: Gingival retraction cord, non-medicated FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gingival retraction cord, non-medicated

StatStix by Centrix, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gingival retraction cord, non-medicated.

R-101 — PASCAL COMPANY, INC. · Class I
Smartcord 2 — EASTDENT Co., Ltd · Class I
roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
Henry Schein — HENRY SCHEIN, INC. · U
roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I

Cleared under the same submission

K200764 also covers:

StatStix — CENTRIX, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Centrix, Inc.

Sources (1)

FDA UDI 714ef112-f380-4aa7-bc26-7d69ef9444f2 34 fields · synced Jun 6, 2026