FDA.reportPublic FDA data

TCS Fresh Concentrated Dental Appliance Cleaner

Primary DI
D8054505FRSMP6
Brand
TCS Fresh Concentrated Dental Appliance Cleaner
Company
THERMOPLASTIC COMFORT SYS
Model
4505FR-SMP
Catalog number
4505FR-SMP
Device description
The TCS Fresh Concentrated Dental Appliance Cleaner is a concentrated cleaning powder for dissolution in water for the cleaning of dentures, partials, nightguards, sportsguards, snoreguards, aligners, and retainers.
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFTCleanser, Denture, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFTCleanser, Denture, Over The CounterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8054505FRSMP6PrimaryHIBCC0
D8054505FRSMP0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleanserAn agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
562-426-2970info@tcsdentalinc.com

Regulatory Flags#

DUNS number
808897776
Device count
75
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D805500301BCUSTOMX100iFlex by TCS5003-01B/CustomX105003-01B/CustomX102025-01-22
D805500301BCUSTOMX10iFlex by TCS5003-01B/CustomX105003-01B/CustomX102024-03-11
D805200301B1X10Karadent by TCS2003-01B/1X102003-01B/1X102024-03-11
D805200301B25Karadent by TCS2003-01B/2-.52003-01B/2-.52024-03-11
D805200301B35Karadent by TCS2003-01B/3-.52003-01B/3-.52024-03-11
D805200301B3X5Karadent by TCS2003-01B/3X52003-01B/3X52024-03-11
D805200301B45Karadent by TCS2003-01B/4-.52003-01B/4-.52024-03-11
D805200301B4X5Karadent by TCS2003-01B/4X52003-01B/4X52024-03-11
D805200301BCUSTOM2Karadent by TCS2003-01/B Custom2003-01/B Custom2024-03-11
D805200301BNX10Karadent by TCS2003-01B/NX102003-01B/NX102024-03-11
D805200301BNX5Karadent by TCS2003-01B/NX52003-01B/NX52024-03-11
D805500301B1X10iFlex by TCS5003-01B/1X105003-01B/1X102024-03-11
D805500301B3X5iFlex by TCS5003-01B/3X55003-01B/3X52024-03-11
D805200001M12Karadent by TCS2000-01/M12000-01/M12023-11-06
D805200001S12Karadent by TCS2000-01/S12000-01/S12023-11-06
D805200301B12Karadent by TCS2003-01/B12003-01/B12023-11-06
D805200501L12Karadent by TCS2005-01/L12005-01/L12023-11-06
D805200501L2212Karadent by TCS2005-01/L22-12005-01/L22-12023-11-06
D805200501LF12Karadent by TCS2000-01/MF12000-01/MF12023-11-06
D805200501M2212Karadent by TCS2005-01/M22-12005-01/M22-12023-11-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810051088649GuruNanda Aligner and Denture Cleaning FoamGurunanda, LLCEFT2026-04-29
00810194403972AiraAIRA, LLCEFT2026-01-16
10810194403979AiraAIRA, LLCEFT2026-01-16
00850078989307SmileSet Universal Cleaning Tablets – 90 pcOrtho Dental Lab LLCEFT2025-09-25
00850078989314SmileSet Universal Cleaning Tablets - Sample 6pcOrtho Dental Lab LLCEFT2025-09-17
00616784487724WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00810180842273WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00855850008061SmilesaverSoluria II LLCEFT2024-06-19
00855850008078SmilesaverSoluria II LLCEFT2024-06-19
00855850008092Guard HealthSoluria II LLCEFT2024-06-19
00855850008108SmilesaverSoluria II LLCEFT2024-06-19
00364031300165SECURE Cleansing TabletsFITTYDENT INTERNATIONAL GmbHEFT2023-10-02
D832200451PlasdentPLASDENT CORPORATIONEFT2023-05-31
D832200450PlasdentPLASDENT CORPORATIONEFT2023-05-31
00665973010878DawnMistDukal LLCEFT2022-12-06
00665973010885DawnMistDukal LLCEFT2022-12-06
D784UZM30011UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
06943566100118Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
06943566107391Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
20665973010872DawnMistDukal LLCEFT2022-12-06
20665973010889DawnMistDukal LLCEFT2022-12-06
00816063021407Cleaning Crystals, PacketteAlign Technology, Inc.EFT2022-12-06
16943566100115Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
16943566107398Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
D784UZM30015UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
00814832015879EFFERDENT ORIGINAL 102CT TAB 6Medtech Products Inc.EFT2022-11-17
00814832015923EFFERDENT PM 90CT TAB 6Medtech Products Inc.EFT2022-11-17
10814832015876EFFERDENT ORIGINAL 102CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
10814832015920EFFERDENT PM 90CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
00814832015862EFFDNT ORIG 44CT TAB 6Medtech Products Inc.EFT2022-11-16