ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece

FDA Device Registration & Listing · Wilmington, DE, US · Registration 3015177652

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015177652
FEI Number
3015177652
Entity Name
ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece
City/State/Country
Wilmington, DE, US
Establishment Address
3411 Silverside Rd Ste 248, Wilmington, DE 19810, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece (Owner Number: 10058983)
Owner / Operator Contact Address
3411 Silverside Road, Suite 248, Wilmington, DE 19810, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Denta-Cool(TM) Ice Cold Mouthpiece(TM) Chemo Mouthpiece(TM)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2020-08-28
DZN Instruments, Dental Hand Dental Class 1 872.4565 2020-08-28
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2020-08-28
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 2020-08-28
EKC Excavator, Dental, Operative Dental Class 1 872.4565 2020-08-28
KYR Bag, Ice General Hospital Class 1 880.6050 2018-11-17
JEX Plier, Orthodontic Dental Class 1 872.4565 2020-08-28

Official Correspondent

David Yoskowitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015177652. Last updated year: 2026. Please use registration number 3015177652 when referencing this establishment in official correspondence.
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