FDA.reportPublic FDA data

MULTIPEG

Primary DI
D785MULTIPEGENG3250
Brand
MULTIPEG
Company
OCO BIOMEDICAL INC
Model
MULTIPEG FOR PENGUIN RFA FOR 3.25 ENGAGE
Catalog number
MULTIPEG ENG 3.25
Device description
MULTIPEG FOR PENGUIN RFA FOR 3.25 ENGAGE
Published
2024-03-12
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
D785MULTIPEGENG3250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant stability measurement pegA small, sterile, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
094146123
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D785OTCAP10010 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 10OT CAP 102026-02-04
D785OTCAP404 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERTOT CAP 4OT CAP 42026-02-04
D785OTPINK404 PACK OT EQUATOR PINK INSERTSOT PINK 4OT PINK 42026-02-04
D785OTPU202 PACK OT EQUATOR IMPRESSION COPINGOT PU 2OT PU 22026-02-04
D785OTYELLOW404 PACK OT EQUATOR YELLOW INSERTOT YELLOW 4OT YELLOW 42026-02-04
D78589490TSI/ERI Locator AbutmentLocator Abutment 0mm89492025-09-03
D785325SB0SCAN BODYTSI/ERI 3.25MM SCAN BODY3.25 SB2024-06-26
D78540SB0SCAN BODYTSI/ERI 4.0MM SCAN BODY4.0 SB2024-06-26
D78550SB0SCAN BODYTSI/ERI 5.0MM SCAN BODY5.0 SB2024-06-26
D78532530SA0SCAN ADAPTER3.25MM ENGAGE PEEK SCAN ADAPTER32530 SA2024-03-12
D78532530SB0SCAN BODY3.25MM ENGAGE SCAN BODY32530 SB2024-03-12
D7854035SA0SCAN ADAPTER4.0MM ENGAGE PEEK SCAN ADAPTER4035 SA2024-03-12
D7854035SB0SCAN BODY4.0MM ENGAGE SCAN BODY4035 SB2024-03-12
D7855045SA0SCAN ADAPTER5.0MM ENGAGE PEEK SCAN ADAPTER5045 SA2024-03-12
D7855045SB0SCAN BODY5.0MM ENGAGE SCAN BODY5045 SB2024-03-12
D7856057SA0SCAN ADAPTER6.0MM ENGAGE PEEK SCAN ADAPTER6057 SA2024-03-12
D7856057SB0SCAN BODY6.0MM ENGAGE SCAN BODY6057 SB2024-03-12
D7850330T0Osteotomy Former3.3mm Osteotomy Former0330TN2024-12-03
D7853610ENGAGE0Two Stage Bone Level Dental ImplantEngage3610 ENGAGE2024-12-03
D7853610ENGPLS0Two Stage Bone Level ImplantEngage Plus3610 Engage Plus2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001170Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
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07908854001460Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001477Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001484Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001491Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001507Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22