FDA.reportPublic FDA data

BIONNOVATION

Primary DI
07899943600728
Brand
BIONNOVATION
Company
BIONNOVATION PRODUTOS BIOMEDICOS LTDA.
Model
13049
Catalog number
13049
Device description
SURGICAL TORQUE WRENCH MANUAL
Published
2023-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899943600728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899943600728078999436007287899943600728

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
903266968
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899943601251BIONNOVATION13138 13138 2023-03-24
07899943601268BIONNOVATION13139 13139 2023-03-24
07899943601299BIONNOVATION13259 13259 2023-03-24
07899943604023BIONNOVATION05088 05088 2023-03-24
07899943604030BIONNOVATION05116 05116 2023-03-24
07899943604047BIONNOVATION05097 05097 2023-03-24
07899943604078BIONNOVATION05086 05086 2023-03-24
07899943604085BIONNOVATION05085 05085 2023-03-24
07899943604092BIONNOVATION05084 05084 2023-03-24
07899943604108BIONNOVATION05073 05073 2023-03-24
07898628610977BIONNOVATION13066 13066 2023-03-23
07898628610984BIONNOVATION13129 13129 2023-03-23
07898628610991BIONNOVATION13130 13130 2023-03-23
07898628611004BIONNOVATION05051 05051 2023-03-23
07898628611011BIONNOVATION05053 05053 2023-03-23
07898628611028BIONNOVATION05055 05055 2023-03-23
07898628611035BIONNOVATION05057 05057 2023-03-23
07898628611042BIONNOVATION13132 13132 2023-03-23
07898628611059BIONNOVATION13133 13133 2023-03-23
07898628611066BIONNOVATION13127 13127 2023-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29