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K-Bond Universal

FDA UDI

Class II (US FDA UDI)

by Spident Co., Ltd.

Identity

Trade Name
K-Bond Universal FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
K-Bond Universal 5ml x 1bottle FDA UDI
Model / Reference
#370400P01 FDA UDI
Description
K-Bond Universal 5ml x 1bottle FDA UDI

Identifiers

Primary DI / UDI-DI
08809262959031 FDA UDI
510(k) Number
K241445 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dentine bonding agent/set

K-Bond Universal by Spident Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K241445 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spident Co., Ltd.

Sources (1)

  • FDA UDI 928c40f6-957d-4ebf-be1f-1c0774cff824 34 fields · synced Jun 1, 2026