FDA.reportPublic FDA data

BMT Medizintechnik GmbH

Primary DI
04251725218447
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
DF-03/13
Catalog number
DF-03/13
Device description
MATRIX FOR PREMOLARS, #13
Published
2020-05-05
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
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251725218447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251725218447042517252184474251725218447

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, reusableA band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461966750pmarcis@bmtsurgical.com

Regulatory Flags#

DUNS number
342582423
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251725200015BMT Medizintechnik GmbH112020-05-05
04251725200022BMT Medizintechnik GmbH13132020-05-05
04251725200039BMT Medizintechnik GmbH17172020-05-05
04251725200046BMT Medizintechnik GmbH18182020-05-05
04251725200053BMT Medizintechnik GmbH222020-05-05
04251725200060BMT Medizintechnik GmbH21212020-05-05
04251725200077BMT Medizintechnik GmbH22222020-05-05
04251725200084BMT Medizintechnik GmbH29292020-05-05
04251725200091BMT Medizintechnik GmbH30302020-05-05
04251725200107BMT Medizintechnik GmbH33332020-05-05
04251725200114BMT Medizintechnik GmbH442020-05-05
04251725200121BMT Medizintechnik GmbH46-L46-L2020-05-05
04251725200138BMT Medizintechnik GmbH48482020-05-05
04251725200152BMT Medizintechnik GmbH51512020-05-05
04251725200169BMT Medizintechnik GmbH51-A51-A2020-05-05
04251725200176BMT Medizintechnik GmbH55552020-05-05
04251725200183BMT Medizintechnik GmbH56562020-05-05
04251725200190BMT Medizintechnik GmbH67-A67-A2020-05-05
04251725200206BMT Medizintechnik GmbH772020-05-05
04251725200213BMT Medizintechnik GmbH707-16D1707-16D12020-05-05

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