FDA.reportPublic FDA data

Luco Hybrid Sleep appliance

Primary DI
00810002220005
Brand
Luco Hybrid Sleep appliance
Company
JOHN'S DENTAL LABORATORY INC
Model
3014680794
Device description
Vivos DNA Wire, Orthodontic
Published
2020-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810002220005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810002220005008100022200058100022200050810002220005

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016649253
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810002220104Abutment/Implant30146807942020-11-18
00810002220272Herbst30146807942023-04-05
00810002220258The Silencer30146807942023-04-03
00810002220265NAPA (Nocturnal Airway Patency Appliance)30146807942023-04-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25