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Alloybond

FDA UDI

Class II (US FDA UDI)

by Sdi , Ltd.

Identity

Trade Name
ALLOYBOND FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Model / Reference
ALLOYBOND CATALYST FDA UDI

Identifiers

Catalog Number
5544012 FDA UDI
Primary DI / UDI-DI
DO3655440121 FDA UDI
510(k) Number
K981383 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

Alloybond by Sdi , 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

K981383 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sdi , Ltd.

Sources (1)

  • FDA UDI 18771e6e-1a0e-4870-86c1-cbe19561aad7 36 fields · synced Jun 1, 2026