Hydro-Cast®

FDA UDI

Class II (US FDA UDI)

by Sultan Healthcare Inc

Identity

Trade Name: Hydro-Cast® FDA UDI
Generic Name: Denture reliner, soft, professional FDA UDI
Device Name: Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher FDA UDI
Model / Reference: 73010 FDA UDI
Description: Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher FDA UDI

Identifiers

Primary DI / UDI-DI: D687730101 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture reliner, soft, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 8 Milliliter FDA UDI
Weight — 120 Gram FDA UDI
Total Volume — 115 Milliliter FDA UDI

Category: Denture reliner, soft, professional

Hydro-Cast® by Sultan Healthcare Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture reliner, soft, professional.

Axcent Acrylics — GARRECO, LLC · Class II
IMMEDIATE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
FLEXACRYL POWDER — Lang Dental Manufacturing Company, Inc. · Class II
TEMPO POWDER — Lang Dental Manufacturing Company, Inc. · Class II
Lynal® Tissue Conditioner and Temporary Reliner — Dentsply International · Class II
Bosworth Trusoft — Harry J. Bosworth Co. · Class II
FLEXACRYL HARD — Lang Dental Manufacturing Company, Inc. · Class II
FLEXACRYL — Lang Dental Manufacturing Company, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sultan Healthcare Inc

Sources (1)

FDA UDI c68f38d5-485d-4d70-bed3-8d1be86a492a 36 fields · synced Jun 8, 2026