FDA.reportPublic FDA data

Dentek

Primary DI
30050428269870
Brand
Dentek
Company
MEDTECH PRODUCTS INC.
Model
00015101203I2
Device description
DNTL GRD 2CT COMFORT CVS
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
30050428269870PackageGS11In Commercial Distribution
00050428274996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3005042826987030050428269870
00050428274996000504282749960504282749960050428274996

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.xx

Regulatory Flags#

DUNS number
060272465
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07392222170504The Doctor's70502020-12-08

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