FDA.reportPublic FDA data

The Doctor's

Primary DI
08711744032548
Brand
The Doctor's
Company
Medtech Products Inc.
Model
1030450
Device description
TD SLEEPZZ 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
08711744032579PackageGS11In Commercial Distribution
08711744032548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08711744032579087117440325798711744032579
08711744032548087117440325488711744032548

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
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
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
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