Vintage Halo

FDA UDI

Class II (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name: Vintage Halo FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: HALO INCISAL POWDER 15G 59 FDA UDI
Model / Reference: 7333 FDA UDI
Description: HALO INCISAL POWDER 15G 59 FDA UDI

Identifiers

Catalog Number: 7333 FDA UDI
Primary DI / UDI-DI: E23573330 FDA UDI
510(k) Number: K973247 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 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

Category: Dental appliance fabrication material, ceramic

Discover the Vintage Halo, a cutting-edge dental material for implantable and removable restorations. This ceramic-based halide is designed using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology, making it ideal for high-quality dental prosthesis fabrication. With its unique properties and compatibility with various CAD software, the Vintage Halo offers unparalleled precision and durability.

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Razor / MegaPlus — U&C International Co., Ltd · Class II
rainbow High shine — Genoss · Class II
Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
CGI — CERAGROUP INDUSTRIES · Class II
ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II

Cleared under the same submission

K973247 also covers:

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 II	Pending data

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

Manufacturer

Manufacturer: Shofu Dental Corp.

Sources (1)

FDA UDI 00a956bf-4c07-420c-a1a1-ca8652debc2b 37 fields · synced Jul 8, 2026