FDA.reportPublic FDA data

SteinerBio

Primary DI
00860010170199
Brand
SteinerBio
Company
STEINER BIOTECHNOLOGY LLC.
Model
SteinerBio Oral Bond
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010170199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010170199008600101701998600101701990860010170199

GMDN Terms#

Term, Definition table
TermDefinition
Clinical periodontal dressingA dental material intended to be used during periodontal procedures to facilitate periodontal tissue healing by providing mechanical, chemical, and/or thermal protection to wounded tissue after surgery or disease, and/or by functioning as a barrier for the prevention of bacterial infiltration in a periodontal pocket after root surface debridement (RSD) and/or planing and root scaling. Some types may adhere to teeth and gums and be used to secure medications, temporary prostheses, and loose teeth. It is available in various forms (e.g., gel in a syringe, fluid in a dispenser with mixing nozzle, substance mixed chairside into a pliable paste). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069907701
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010170106SteinerBioSteinerBio Socket Graft 0.5 cc2023-04-21
00860010170113SteinerBioSteinerBio Socket Graft 1.0 cc2023-04-21
00860010170120SteinerBioSteinerBio Socket Graft Plus 0.5 cc2023-04-21
00860010170137SteinerBioSteinerBio Socket Graft Plus 1.0 cc2023-04-21
00860010170144SteinerBioSteinerBio Socket Graft Injectable 1.0 cc2023-04-21
00860010170151SteinerBioSteinerBio Immediate Graft2023-04-21
00860010170168SteinerBioSteinerBio BioDensification2023-04-21
00860010170175SteinerBioSteinerBio Ridge Graft Kit2023-04-21
00860010170182SteinerBioSteinerBio Sinus Graft2023-04-21
00860010170205SteinerBioSteinerBio OsseoConduct Perio Granules 250-500 mic2023-04-21
00860010170212SteinerBioSteinerBio OsseoConduct Perio Granules 250-500 mic2023-04-21
00860010170229SteinerBioSteinerBio OsseoConduct Standard Granules 500-10002023-04-21
00860010170236steinerBioSteinerBio OsseoConduct Standard Granules 500-10002023-04-21
00860010170243SteinerBioSteinerBio OsseoConduct Macro Granules 1000-2000 m2023-04-21
00860010170250SteinerBioSteinerBio OsseoConduct Macro Granules 1000-2000 m2023-04-21
00860010170267SteinerBioSteinerBio OsseoConduct Micron2023-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29
10386040003896Miracle Mix®Gc America Inc.EMA2022-07-13
10386040008716GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008723GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008730GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008747GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008754GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008761GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008778GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008785GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008792GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008808GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008815GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008822GC Fuji II LC®Gc America Inc.EMA2022-07-13