FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040188217
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
4220005
Catalog number
4220005
Device description
Zirlux Nightguard & Splint Print Resin - Rigid
Published
2024-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040188217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040188217003040401882173040401882170304040188217

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
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00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
D745701164RSN00070Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, IncMQC2023-04-11
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCMQC2023-03-28
H66842000111KeyPrintKeystone IndustriesMQC2023-02-20
H66842001611KeyPrintKeystone IndustriesMQC2023-02-20
H66842200111KeyPrintKeystone IndustriesMQC2023-02-20
H66842201141HeyGearsKeystone IndustriesMQC2023-02-20
H66842201611KeyPrintKeystone IndustriesMQC2023-02-20
H66850524011Nexa3DKeystone IndustriesMQC2023-02-20
H66852233011Nexa3DKeystone IndustriesMQC2023-02-20
H668D6400231PearsonKeystone IndustriesMQC2023-02-20
H668D6400241PearsonKeystone IndustriesMQC2023-02-20
H668D6400271PearsonKeystone IndustriesMQC2023-02-20
H668210041American DentalKeystone IndustriesMQC2022-11-30
H668210051American DentalKeystone IndustriesMQC2022-11-30
H668210061American DentalKeystone IndustriesMQC2022-11-30
H66870001901ProformKeystone IndustriesMQC2022-11-30
H6687000190R11ProformKeystone IndustriesMQC2022-11-30
H6687000190R21ProformKeystone IndustriesMQC2022-11-30
H66870001911ProformKeystone IndustriesMQC2022-11-30
H6687000191R11ProformKeystone IndustriesMQC2022-11-30
H6687000191R21ProformKeystone IndustriesMQC2022-11-30
H66870001921ProformKeystone IndustriesMQC2022-11-30