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
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
30087701429492Good Neighbor90-3482024-09-18
30087701429980Good Neighbor90-55012024-09-18

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
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
00033732010306LunaGuardMcKeon Products, Inc.OBR2022-10-07