FDA.reportPublic FDA data

BMT Medizintechnik GmbH

Primary DI
04251725215026
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
OP-1
Catalog number
OP-1
Device description
BALL BURNISHER, ROUND, #1
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251725215026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251725215026042517252150264251725215026

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. 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
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251725206727BMT Medizintechnik GmbHDL-60DL-602020-05-05
04251725206895BMT Medizintechnik GmbHDL-CDL-C2020-05-05
04251725206901BMT Medizintechnik GmbHDL-VDL-V2020-05-05
04251725207519BMT Medizintechnik GmbHDP-24DP-242020-05-05
04251725214111BMT Medizintechnik GmbHMRT-6MRT-62020-05-05
04251725214128BMT Medizintechnik GmbHMRT-7MRT-72020-05-05
04251725214135BMT Medizintechnik GmbHMRT-C1MRT-C12020-05-05
04251725214142BMT Medizintechnik GmbHMRT-C3MRT-C32020-05-05
04251725214159BMT Medizintechnik GmbHMRT-C4MRT-C42020-05-05
04251725214166BMT Medizintechnik GmbHMRT-C7MRT-C72020-05-05
04251725216153BMT Medizintechnik GmbHPH-60PH-602020-05-05
04251725224233BMT Medizintechnik GmbHDP-136DP-1362020-05-05
04251725205973BMT Medizintechnik GmbHDB-180DB-1802020-05-05
04251725205980BMT Medizintechnik GmbHDB-181DB-1812020-05-05
04251725205997BMT Medizintechnik GmbHDB-182DB-1822020-05-05
04251725211691BMT Medizintechnik GmbHFO-162FO-1622020-05-05
04251725211707BMT Medizintechnik GmbHFO-163FO-1632020-05-05
04251725211714BMT Medizintechnik GmbHFO-165FO-1652020-05-05
04251725211820BMT Medizintechnik GmbHFO-33FO-332020-05-05
04251725220105BMT Medizintechnik GmbHDB-177DB-1772020-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021511B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102151H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102157H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102158H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102159H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910217U150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223C1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223GF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791022NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791023AU150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791026QW0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP02H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102GFP0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102W11B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102WGF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
B382SD19300Surgical DirectSurgical Direct, Inc.EIX2026-07-31
08057639712677Needle tip - BLKMC BIO SRLEIX2026-07-28
08057639712684Needle tipMC BIO SRLEIX2026-07-28
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08