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Disposable Soft Cups (white)

FDA UDI

Class I (US FDA UDI)

by Bonart Co., Ltd.

Identity

Trade Name
DISPOSABLE SOFT CUPS (WHITE) FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Model / Reference
DPA-101 FDA UDI

Identifiers

Primary DI / UDI-DI
04719873121090 FDA UDI
510(k) Number
K162856 FDA UDI
FDA Product Code
EGS FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental polishing cup, single-use

Disposable Soft Cups (white) by Bonart Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental polishing cup, single-use.

Cleared under the same submission

K162856 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bonart Co., Ltd.

Sources (1)

  • FDA UDI b181de97-af41-43f3-a000-280e0c3c0b9f 33 fields · synced Jun 8, 2026