FDA.reportPublic FDA data

Smile Spa

Primary DI
00850007728151
Brand
Smile Spa
Company
Access Dental Lab, LLC
Model
100-0367
Device description
Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more.
Published
2019-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007728151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007728151008500077281518500077281510850007728151

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance automated cleanerAn electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-361-0576JOE.MILLER@ACCESSDENTALLAB.COM

Regulatory Flags#

DUNS number
054012763
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007728427SmileDirectClub Retainer 140-00042023-11-30
00850007728410ALIGNER SEATER PURPLE220-00052023-02-17
00850007728243SDC impression material (Zest)200-01062023-02-17
00850007728250SDC-impression material (Kulzer)200-01072023-02-17
00850007728342Smile stretcher-purple bag200-00492023-02-17
00850007728366Impression Tray XSM200-00112023-02-17
00850007728373IMPRESSION TRAY SM200-00122023-02-17
00850007728380IMPRESSION TRAY MED200-00132023-02-17
00850007728397IMPRESSION TRAY LRG200-00142023-02-17
00850007728403IMPRESSION TRAY XLG200-00152023-02-17
00850007728274SDC ALIGNERS MCC100-00102022-12-09
00850007728281SDC Aligners-REF100-00122022-12-09
00850007728298SDC Aligners-REP100-03552022-12-09
00850007728304NIGHTTIME CLEAR ALIGNERS100-03622022-12-09
00850007728311NIGHTTIME ALIGNERS-MCC100-03632022-12-09
00850007728328NIGHTTIME ALIGNERS - REF100-03642022-12-09
00850007728335NIGHTTIME -REP100-03652022-12-09
00850007728267SDC Aligners-100-03522022-12-07
00850007728052electric toothbrush100-03562019-08-14
00850007728069Electric Toothbrush100-03572019-08-14

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H816PREZF128Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
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