FDA.reportPublic FDA data

Ola Fresh Dental Appliance Cleanser

Primary DI
D805OLA120
Brand
Ola Fresh Dental Appliance Cleanser
Company
THERMOPLASTIC COMFORT SYS
Model
OLA12
Catalog number
OLA12
Device description
The Ola Fresh Dental Appliance Cleanser 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
Rx
false
OTC
true
Sterile
false
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
D805OLA122PrimaryHIBCC0
D805OLA120Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808897776
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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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