FDA.reportPublic FDA data

The Doctor's

Primary DI
00042037799328
Brand
The Doctor's
Company
Medtech Products Inc.
Model
79932E
Device description
TD NIGHTGUARD ADVANCED CND 12
Published
2020-12-08
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
10042037799325PackageGS11In Commercial Distribution
00042037799328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004203779932510042037799325
00042037799328000420377993280420377993280042037799328

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
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
07392222170504The Doctor's70502020-12-08
10058790005603TheraTears STERILID AM 2OZ SPRY 24587900005602023-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810036601252Zero GrindDental Choice Holdings LLCOBR2026-10-20
00810036601344CustMbiteDental Choice Holdings LLCOBR2026-10-20
00810036601795Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036602020Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036602457Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036602525Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036602532Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036603676Disco DreamsDental Choice Holdings LLCOBR2026-10-20
00810036603683Disco DreamsDental Choice Holdings LLCOBR2026-10-20
00810036604574KloudDental Choice Holdings LLCOBR2026-10-20
00810036604796Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036604802Rest In PeaceDental Choice Holdings LLCOBR2026-10-20
00810036604956Protect The CrownDental Choice Holdings LLCOBR2026-10-20
00810036604963Protect The CrownDental Choice Holdings LLCOBR2026-10-20
00810036606127KloudDental Choice Holdings LLCOBR2026-10-20
00810036606721BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810036606738BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810036608992Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036609005Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810036609012Sleep PeachyDental Choice Holdings LLCOBR2026-10-20
00810180630924CustMbiteDental Choice Holdings LLCOBR2026-10-20
00810180631013BruxArmorDental Choice Holdings LLCOBR2026-10-20
00810180631020Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631037Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631044Just SmileDental Choice Holdings LLCOBR2026-10-20
00810180631914ResolveDental Choice Holdings LLCOBR2026-10-20
00810180631921ResolveDental Choice Holdings LLCOBR2026-10-20
00810180631938ResolveDental Choice Holdings LLCOBR2026-10-20
00850018499316DreamEZDental Choice Holdings LLCOBR2026-10-20
00850018499323DreamEZDental Choice Holdings LLCOBR2026-10-20