FDA.reportPublic FDA data

NAPA (Nocturnal Airway Patency Appliance)

Primary DI
00810002220265
Brand
NAPA (Nocturnal Airway Patency Appliance)
Company
JOHN'S DENTAL LABORATORY INC
Model
3014680794
Device description
A removable intraoral device intended to reduce both mild Obstructive Sleep Apnea and snoring. This is a reusable device.
Published
2023-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
LQZDevice, Jaw Repositioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQZDevice, Jaw RepositioningDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902790000NAPAG-Ortho Lab1990-09-19LQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810002220265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810002220265008100022202658100022202650810002220265

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016649253
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810002220104Abutment/Implant30146807942020-11-18
00810002220272Herbst30146807942023-04-05
00810002220258The Silencer30146807942023-04-03
00810002220241The Luco Hybrid OSA Appliance30146807942023-03-28
00810002220234Vivos mRNA30146807942023-03-28
00810002220166Vivos Dorsal mRNA 30146807942023-02-14
00810002220159Vivos DNA-Lower30146807942022-06-13
00810002220111mmRNA appliance30146807942022-02-04
00810002220012Vivos DNA30146807942020-09-08
00810002220173KeyPrint KeySplint Soft30146807942023-04-04
00810002220128Digital Denture30146807942020-11-25
00810002220098Herbst30146807942020-09-23
00810002220142Vivos mmRNA appliance30146807942023-03-28
00810002220210OASYS (Oral/Nasal Airway System)30146807942023-03-28
00810002220203EMA (Elastic Mandibular Advancement appliance)30146807942023-03-27
00810002220043Silencer30146807942020-09-23
00810002220081NAPA (Nocturnal Airway Patency Appliance)30146807942020-09-23
00810002220050TAP (Thornton Adjustable Positioner)30146807942020-09-23
00810002220067TAP (Thornton Adjustable Positioner) 330146807942020-09-23
00810002220074OASYS (Oral/Nasal Airway System)30146807942020-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850077473791EMA 3DEMA SLEEP INCORPORATEDLQZ2026-04-14
00860008847522KAVA DORSAL DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
00860008847539KAVA HERBST DUAL LAMINATEAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-04-14
D775CSAA0NAPA ApplianceGreat Lakes Dental Technologies, Ltd.LQZ2026-04-13
00860008847508KAVA DORSAL ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
00860008847515KAVA HERBST ACRYLICAPEX DENTAL SLEEP LAB INCORPORATEDLQZ2026-03-18
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