FDA.reportPublic FDA data

DENTALAIRE

Primary DI
00990010306332
Brand
DENTALAIRE
Company
Beyes Dental Canada Inc
Model
DA400LEDMH
Catalog number
Dentalaire LED kit
Device description
DA400LEDMH, LED High Speed Handpiece Retrofit any air powered dental station with LED lighting
Published
2023-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00990010306332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00990010306332009900103063329900103063320990010306332

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental handpiece couplerA short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
244261462
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00990010312418DURAY2D2025-12-15
00990010312562DURAY3D2025-12-15
00990010312579DURAYART PLUS2025-12-15
00990010312586DURAY2D CEPH2025-12-15
00990010312593DURAY3D CEPH2025-12-15
00990010312609DURAYART PLUS C2025-12-15
00990010301290DURAYDC1001DC12023-05-11
00837699000109DURAYDC10012022-10-06
00990010306653Comfort-Sonic UL2214K-92024-01-19
00990010306660Comfort-Sonic UL2215K-102024-01-19
00990010306677Comfort-Sonic UL2216K-112024-01-19
00990010306684Comfort-Sonic UL2217K-602024-01-19
00990010306691Comfort-Sonic UL2218K-612024-01-19
00990010306707Comfort-Sonic UL2219K-622024-01-19
00990010306714Comfort-Sonic UL2220K-A112024-01-19
00990010306721Comfort-Sonic UL2221K-E82024-01-19
00990010306738Comfort-Sonic UL2222K-512024-01-19
00990010306462Beyes849961FG 582023-12-28
00990010306479Beyes889904FG 58L2023-12-28
00990010306486Beyes889905FG SS 5592023-12-28

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Primary DI, Brand, Company table
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00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11