FDA.reportPublic FDA data

Propel

Primary DI
00852673007004
Brand
Propel
Company
PROPEL ORTHODONTICS LLC
Model
ASM-20010
Catalog number
ASM-20010
Device description
Perforation Device, Propel XL
Published
2016-12-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150392000PROPEL devicePropel Orthodontics, LLC2015-09-18DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852673007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852673007004008526730070048526730070040852673007004

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
408 394 5851bw@propelortho.com

Regulatory Flags#

DUNS number
117334253
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852673007073PropelASM-20021ASM-200212018-03-06
00852673007103VProASM-200182020-03-23
00852673007240Acceledent OptimaASM-200312020-07-31
00852673007189VPro+ASM-200232020-03-17
00852673007127HyperByteASM-20018-052020-01-14
00852673007011PropelASM-20018ASM-200182016-12-28
00852673007028PropelASM-20010-04ASM-20010-042016-12-28
00852673007035PropelASM-20010-01ASM-20010-012016-12-28
00852673007042PropelASM-20010-03ASM-20010-032016-12-28
00852673007059PropelASM-20010-02ASM-20010-022016-12-28
00852673007066PropelASM-20022ASM-200222018-03-06
00852673007080PropelASM-20018-04ASM-20018-042018-03-09
00852673007097PropelASM-200232018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652772TPXSTRYKER CORPORATIONDZJ2026-04-13
00810007633343AccuPlan SystemMedcadDZJ2025-10-31
00810007633350AccuPlan SystemMedcadDZJ2025-10-31
00810007633367AccuPlan SystemMedcadDZJ2025-10-31
00810007633374AccuPlan SystemMedcadDZJ2025-10-31
00810007633381AccuPlan SystemMedcadDZJ2025-10-31
00810007633336AccuPlan System MedcadDZJ2025-10-30
00840124524255FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00840124524262FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00810007633183AccuPlan System MedcadDZJ2024-10-18
00810007633190AccuPlan System MedcadDZJ2024-10-18
00810007633213AccuPlan System MedcadDZJ2024-10-18
00810007633220AccuPlan System MedcadDZJ2024-10-18
00810007633237AccuPlan System MedcadDZJ2024-10-18
00810007631547AccuPlan SystemMedcadDZJ2023-11-30
00810007632209AccuPlan SystemMedcadDZJ2023-11-02
00810007632223AccuPlan SystemMedcadDZJ2023-11-02
00810007631202AccuPlan System MedcadDZJ2023-11-01
00810007631257AccuPlan System MedcadDZJ2023-11-01
00810007631264AccuPlan SystemMedcadDZJ2023-11-01
00810007631561AccuPlan SystemMedcadDZJ2023-11-01
00810007631677AccuPlan System MedcadDZJ2023-11-01
00810007631813AccuPlan System MedcadDZJ2023-11-01
00810007631820AccuPlan System MedcadDZJ2023-11-01
00810007631851AccuPlan System MedcadDZJ2023-11-01
00810007631875AccuPlan System MedcadDZJ2023-11-01
00810007631905AccuPlan System MedcadDZJ2023-11-01
00810007631912AccuPlan System MedcadDZJ2023-11-01
00810007631929AccuPlan System MedcadDZJ2023-11-01
00810007631936AccuPlan System MedcadDZJ2023-11-01