FDA.reportPublic FDA data

Good Neighbor Pharmacy

Primary DI
20087701190661
Brand
Good Neighbor Pharmacy
Company
Amerisourcebergen Drug Corporation
Model
SQN54
Device description
Classic Dental Guard 2 Dental Guards, Storage Case and Fitting Tray SQN54
Published
2025-03-03
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

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
20087701190661PackageGS16In Commercial Distribution
00087701190667PrimaryGS10
10087701190664Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2008770119066120087701190661
00087701190667000877011906670877011906670087701190667
1008770119066410087701190664

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007914906
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00087701190803Good Neighbor Pharmacy Freeze Skin Tag Remover1500-11112026-09-26
00087701190810Good Neighbor Pharmacy103056022026-07-08
00087701190797good neighbor pharmacy7W92629C12026-06-01
00087701432699Good Neighbor Pharmacy611646102336602025-08-13
00087701432866Good Neighbor Pharmacy611646102336702025-08-13
00087701432910Good Neighbor Pharmacy611646102336802025-08-13
00087701432927Good Neighbor Pharmacy611646102336542025-08-13
00087701190667Good Neighbor PharmacySQN542025-03-03
00087701429477Good Neighbor90-3632024-09-26
00087701429484Good Neighbor90-3312024-09-26
30087701429478Good Neighbor90-3632024-09-26
30087701429485Good Neighbor90-3312024-09-26
00087701427404Good Neighbor90-50D2024-09-18
00087701427411Good Neighbor90-50K2024-09-18
00087701429491Good Neighbor90-3482024-09-18
00087701429989Good Neighbor90-55012024-09-18
00087701430145Good Neighbor90-3102024-09-18
00087701430152Good Neighbor90-5102024-09-18
30087701427405Good Neighbor90-50D2024-09-18
30087701427412Good Neighbor90-50K2024-09-18

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