FDA.reportPublic FDA data

Dentek

Primary DI
00047701000557
Brand
Dentek
Company
DenTek Oral Care, Inc.
Model
10047701000554
Device description
DNTK FRSH PROTECT 32CT GRD 12
Published
2022-10-05
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
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10047701000554PackageGS132In Commercial Distribution
00047701000557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004770100055410047701000554
00047701000557000477010005570477010005570047701000557

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-6835xx@xx.com

Regulatory Flags#

DUNS number
153818646
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00047701001813Dentek100477010018102024-06-19
00047701000403Dentek10047701000400A2020-07-14
00047701000410Dentek100477010004172020-12-08
00047701000717DENTEK CROSS FLOSSER 75CT FLS PICK 36200477010007112022-10-21
00047701000816DENTEK ADVANCED TRIPLE CLEAN 90CT FLOSS PICK 36100477010008132022-10-20
00047701000847DENTEK FUN 90CT FUN FLOSSER 36200477010008412022-10-21
00047701000922DENTEK CMF CLEAN 90CT FLOSS PICK 72100477010009292022-10-21
00047701001127DENTEK EARTH FRNDLY TRPL 60CT PICK 30100477010011242022-10-21
00047701001134DENTEK EASY BRUSH STD 10CT IDBR 36100477010011312022-10-07
00047701001202Dentek00038904806A2020-10-06
00047701001516Dentek00015101203I22020-07-14
00047701001745DNTK FRSH BREATH 90CT FLS PICK 36200477010017492022-10-21
00047701001752Dentek100477010017592022-10-05
00047701001905DENTEK ADVANCED TRIPLE CLEAN 150CT FLOSS PICK 30500477010019002022-10-20
00047701001950DENTEK CMF CLEAN 150CT FLOSS PICK 30200477010019542022-10-21
00047701002032DENTEK EASY BRUSH STD 16CT IDBR 36100477010020392022-10-11
00047701002100DENTEK FUN 75CT FLOSSER 36100477010021072022-10-21
00047701002155DENTEK CMPLT CLEAN BK 75CT FLS PICK 72100477010021522022-10-21
00047701002247DENTEK SLIM BRUSH 32CT IDBR 36100477010025412022-10-11
00047701002407DENTEK DEEP CLEAN 100CT IDBR 24100477010024042022-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013500733Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860013500740Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860015217721enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217738enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217707enCore Night GuardENCORE LABORATORY LLCOBR2026-01-08
00692121032055SleepRightSplintek Inc.OBR2025-12-17
00692121032062SleepRightSplintek Inc.OBR2025-12-17
00692121032246SleepRightSplintek Inc.OBR2025-12-17
00692121035438SleepRightSplintek Inc.OBR2025-12-17
00860013500702Custom Night GuardGrindGuard Inc.OBR2025-03-17
00087701190667Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
20087701190661Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
00195515045247Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
10195515045244Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
00651080651523PlackersRANIR, LLCOBR2024-04-26
10651080651520PlackersRANIR, LLCOBR2024-04-26
00713733567404MeijerMEIJER, INC.OBR2024-04-17
00050428270691CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
10050428270698CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
00311917046877WalgreensWALGREEN CO.OBR2024-01-18
10311917046874WalgreensWALGREEN CO.OBR2024-01-18
00692121035216SleepRightSplintek Inc.OBR2023-08-30
00866618000036GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000043GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000050GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
10866618000033GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00858286007646SOVAAkervall Technologies, Inc.OBR2023-02-07