FDA.reportPublic FDA data

MatrixMANDIBLE

Primary DI
H980SD3178790
Brand
MatrixMANDIBLE
Company
Synthes GmbH
Model
SD317.879
Catalog number
SD317879
Device description
MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/50MM
Published
2022-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDRILL, BONE, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043310000SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)2005-01-05HWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587002538PrimaryGS10
H980SD3178790SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758700253810887587002538

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22