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Calciject

FDA UDI

Class II (US FDA UDI)

by Centrix, Inc.

Identity

Trade Name
Calciject FDA UDI
Generic Name
Calcium hydroxide dental suspension FDA UDI
Device Name
Calciject prefilled Calcium Hydroxide paste tips, 24 FDA UDI
Model / Reference
320003 FDA UDI
Description
Calciject prefilled Calcium Hydroxide paste tips, 24 FDA UDI

Identifiers

Primary DI / UDI-DI
00817051020822 FDA UDI
510(k) Number
K001050 FDA UDI
FDA Product Code
EJK FDA UDI
GMDN Term
Calcium hydroxide dental suspension FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3250 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

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: Calcium hydroxide dental suspension

Calciject by Centrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Calcium hydroxide dental suspension.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centrix, Inc.

Sources (1)

  • FDA UDI 20119ddf-ec3b-4483-9afa-256b6fbb938b 34 fields · synced Jun 1, 2026