Henry Schein

FDA UDI

Class U (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Gingival retraction kit FDA UDI
Device Name: Retreat GRP Capsule FDA UDI
Model / Reference: 5700348 FDA UDI
Description: Retreat GRP Capsule FDA UDI

Identifiers

Catalog Number: 5700348 FDA UDI
Primary DI / UDI-DI: 10304040025960 FDA UDI
510(k) Number: K050180 FDA UDI
FDA Product Code: MVL FDA UDI
GMDN Term: Gingival retraction kit FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Dimensions & Sizes

Size: Weight — 1 Gram FDA UDI

Category: Gingival retraction kit

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

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Cleared under the same submission

K050180 also covers:

ACTEON — ACTEON MANUFACTURING
EXPASYL strawberry flavor — ACTEON MANUFACTURING
EXPASYL x20 — ACTEON MANUFACTURING
EXPASYL x6 — ACTEON MANUFACTURING
Henry Schein — HENRY SCHEIN, INC.
Henry Schein — HENRY SCHEIN, INC.
Henry Schein — HENRY SCHEIN, 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: Henry Schein, Inc.

Sources (1)

FDA UDI 0b4c4cef-2180-4b42-80fc-8aed35714dc6 37 fields · synced Jun 1, 2026