FDA.reportPublic FDA data

The Doctor's

Primary DI
07392222170504
Brand
The Doctor's
Company
Medtech Products Inc.
Model
7050
Device description
TD EKULF NIGHTGUARD 1CT PAD 12
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
27392222170508PackageGS11In Commercial Distribution
07392222170504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2739222217050827392222170508
07392222170504073922221705047392222170504

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-592-6661xx@xx.xx

Regulatory Flags#

DUNS number
060272465
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
08711744032548The Doctor's10304502020-12-08
00042037799229The Doctor's 79922B2020-07-14
00042037799328The Doctor's79932E2020-12-08
00075137000148Compound W®NitroFreeze Yellow CWUS009101N/A2020-01-16
00075137000155Wartner®WPUS0011012020-01-13
00075137440340Compound W®CW017201, CW0121052016-09-16
00075137530058Compound W®CW017201, CW0171052016-09-16
00678112653218Clear Eyes®CE063404, CE063104 2016-09-16
00814832010300EFFERGRIP ADHESIVE 1.5OZ TUBE 24108148320103072022-10-07
00814832010317EFFERGRIP ADHESIVE 2.5OZ TUBE 12108148320103142022-10-07
00814832015862EFFDNT ORIG 44CT TAB 6108148320158692022-11-16
00814832015879EFFERDENT ORIGINAL 102CT TAB 6108148320158762022-11-17
00814832015886EFFDNT ORIG 126CT TAB 6108148320158832022-09-28
00814832015893EFFDNT PLUS MNT 44CT TAB 6108148320158902022-11-16
00814832015909EFFDNT PLUS MNT 90CT TAB 6108148320159062022-11-16
00814832015916EFFDNT PLUS MNT 126CT TAB 6 108148320170542022-09-28
00814832015923EFFERDENT PM 90CT TAB 6108148320159202022-11-17
00814832015930EFFDNT ORIG 252ct CLUB (2x126CT) TAB 12108148320159372022-09-28
00814832017354EFFDNT PM 126CT TAB 6108148320173512022-09-28
10058790005603TheraTears STERILID AM 2OZ SPRY 24587900005602023-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810036604284Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604291Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604307Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604314Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604901Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604932Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036606783America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036607353America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036601245RestwellDental Choice Holdings LLCOBR2026-10-23
00810036601801Wake RightDental Choice Holdings LLCOBR2026-10-23
00810036604185Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604192Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604208Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604246Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604253Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604758La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604970La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604987La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604994La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036605007La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036606714BruxArmorDental Choice Holdings LLCOBR2026-10-23
00810036606813ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606820ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606837ResolveDental Choice Holdings LLCOBR2026-10-23
00810036607520KloudDental Choice Holdings LLCOBR2026-10-23
00810036607537KloudDental Choice Holdings LLCOBR2026-10-23
00810036607544Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607551Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607599Sleep PeachyDental Choice Holdings LLCOBR2026-10-23
00810036607605Sleep PeachyDental Choice Holdings LLCOBR2026-10-23