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REGENX PuraCAL

FDA UDI

Class II (US FDA UDI)

by Ace Surgical Supply Co., Inc.

Identity

Trade Name
REGENX PuraCAL FDA UDI
Generic Name
Dental root surface conditioner FDA UDI
Device Name
PuraCAL .5g Kit Medical Grade Calcium Sulfate FDA UDI
Model / Reference
PGCS05 FDA UDI
Description
PuraCAL .5g Kit Medical Grade Calcium Sulfate FDA UDI

Identifiers

Catalog Number
PGCS05 FDA UDI
Primary DI / UDI-DI
00614950008681 FDA UDI
FDA Product Code
LYC FDA UDI
GMDN Term
Dental root surface conditioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Category: Dental root surface conditioner

REGENX PuraCAL by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental root surface conditioner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ace Surgical Supply Co., Inc.

Sources (1)

  • FDA UDI ca0407b1-dedc-486f-838c-acfbc11e43ca 36 fields · synced May 30, 2026