FDA.report

MEDENTiKA

Primary DI
EMKA514029
Brand
MEDENTiKA
Company
MEDENTiKA GmbH
Model
5-14-02
Catalog number
5-14-02
Device description
Cortical drill
Published
2020-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251574805782PrimaryGS10
EMKA514029SecondaryHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)448-8168Info.usa@straumann.com

Regulatory Flags

DUNS number
537555497
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

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04251574865755MedentikaE 1400-SBE 1400-SB2025-09-19
04251574865762MedentikaE 1410-SBE 1410-SB2025-09-19
04251574865779MedentikaE 1420-SBE 1420-SB2025-09-19
04251574865786MedentikaE 1430-SBE 1430-SB2025-09-19
04251574865823MedentikaEV 1400-SBEV 1400-SB2025-09-19
04251574865830MedentikaEV 1410-SBEV 1410-SB2025-09-19
04251574865847MedentikaEV 1420-SBEV 1420-SB2025-09-19
04251574865854MedentikaEV 1430-SBEV 1430-SB2025-09-19
04251574865861MedentikaEV 1440-SBEV 1440-SB2025-09-19
04251574865892MedentikaF 1400-SBF 1400-SB2025-09-19
04251574865908MedentikaF 1410-SBF 1410-SB2025-09-19
04251574865915MedentikaF 1420-SBF 1420-SB2025-09-19
04251574865960MedentikaH 1400-SBH 1400-SB2025-09-19
04251574865977MedentikaH 1410-SBH 1410-SB2025-09-19
04251574866011MedentikaI 1400-SBI 1400-SB2025-09-19
04251574866028MedentikaI 1410-SBI 1410-SB2025-09-19

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