FDA.reportPublic FDA data

Vector R&D, Inc

Primary DI
00810113690995
Brand
Vector R&D, Inc
Company
Vector R&D, Inc.
Model
HAP-4
Catalog number
HAP-4
Device description
Alpha-Air Professional Autochuck - 4 hole
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093084000ROLENCE DENTAL HIGH SPEED HANDPIECE, RHPRolence Ent., Inc.2009-12-16EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113690995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113690995008101136909958101136909950810113690995

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, pneumaticA pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(253)263-7208mattr@vectorusa.net

Regulatory Flags#

DUNS number
825399723
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113691152Vector R&D, IncEPS-UEPS-U2024-02-09
00810113691169Vector R&D, IncVx9-SSVx9-SS2024-02-09
00810113691176Vector R&D, IncVx9-SLSVx9-SLS2024-02-09
00810113691145Vector R&D, IncVM201LVM201L2023-03-08
00810113691015Vector R&D, IncTT-ECRATT-ECRA2023-02-07
00810113691022Vector R&D, IncMT-20PDXMT-20PDX2023-02-07
00810113691039Vector R&D, Inc10-HE10-HE2023-02-07
00810113691046Vector R&D, Inc10-HEL-E10-HEL-E2023-02-07
00810113691053Vector R&D, Inc10-HE-S10-HE-S2023-02-07
00810113691060Vector R&D, Inc10-HEL-S10-HEL-S2023-02-07
00810113691077Vector R&D, IncVM45LVM45L2023-02-07
00810113691084Vector R&D, IncVM20LP/KV68VM20LP/KV682023-02-07
00810113691091Vector R&D, IncVM10-SGVM10-SG2023-02-07
00810113691107Vector R&D, IncVM10L-SGVM10L-SG2023-02-07
00810113691114Vector R&D, IncVSSVSS2023-02-07
00810113691121Vector R&D, IncVSS5VSS52023-02-07
00810113691138Vector R&D, IncVSS6VSS62023-02-07
00810113690001Vector R&D, IncVx10-SLKVx10-SLK2022-09-30
00810113690018Vector R&D, IncVx10-SKVx10-SK2022-09-30
00810113690025Vector R&D, IncVx9-SLKVx9-SLK2022-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
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