FDA.reportPublic FDA data

SML

Primary DI
D854620651
Brand
SML
Company
SELANE PRODUCTS, INC.
Model
62065
Device description
The POD
Published
2020-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182820000The PODAdvanced Facialdontics, LLC2019-07-17MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D854620651PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
066642729
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D854413871967328267319ApnoDentApnoDent2026-05-29
D85463260S1SML63260S2017-08-04
D85463603AACS1SML63603AACS2017-08-04
D85463603AAO2S1SML63603AAO2S2017-08-04
D85463603AAS1SML63603AAS2017-08-04
D85463603ACO2S1SML63603ACO2S2017-08-04
D85463603ALCS1SML63603ALCS2017-08-04
D85463603AO2S1SML63603AO2S2017-08-04
D85463603AS1SML63603AS2017-08-04
D85463603L1SML63603L2017-08-04
D85463603LS1SML63603LS2017-08-04
D85463603NS1SML63603NS2017-08-04
D85463603PMTS1SML63603PMTS2017-08-04
D85463603WS1SML63603WS2017-08-04
D85460994LS1SML60994LS2017-08-04
D85460994S1SML60994S2017-08-04
D85463224S1SML63224S2017-08-04
D85463225AHS1SML63225AHS2017-08-04
D85463225AS1SML63225AS2017-08-04
D85463226S1SML63226S2017-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
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