FDA.report

ZOLL-DENTAL

Primary DI
00840105206293
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
OPB-SP-2028
Device description
SP-2028
Published
2020-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKJBURNISHER, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840105206293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105206293008401052062938401052062930840105206293

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags

DUNS number
005449822
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105223733ZOLLDENTALS-ST22025-03-17
00840105223726ZOLL DENTALZ-73012025-01-29
00840105223672ZOLL DENTALZ-13022024-12-18
00840105223689ZOLL DENTALZ-13032024-12-18
00840105223696ZOLL DENTALZ-47862024-12-18
00840105223702ZOLL DENTALZ-47872024-12-18
00840105223719ZOLL DENTALZ-47902024-12-18
00840105223658ZOLL DENTALZ-52585052024-12-11
00840105223665ZOLL DENTALZ-48205052024-12-11
00840105223641ZOLL DENTALZ-49862024-08-26
00840105223634ZOLL DENTALRET-UofMN-BENT2024-08-01
00840105223573ZOLL DENTALZ-49332024-07-29
00840105223597ZOLL DENTALZ-90322024-07-29

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00840018671508Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018666139Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018662247Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840018662896Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
05010058178090InstrapacROBINSON HEALTHCARE LIMITEDEKJ2025-06-23
00889813065884Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065891Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065907Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065914Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065921Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065945Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066157Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065938Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-10-01
00813677025159PDT, Inc.PDT, INC.EKJ2024-09-11
00813677025166PDT, Inc.PDT, INC.EKJ2024-09-11
00842517118652Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118669Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118676Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
08800075604774OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-03-04
08800075604750OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075604767OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075624000OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08964003163297NivoB. Ali ImpexEKJ2024-01-27
08964003163303NivoB. Ali ImpexEKJ2024-01-27
10889950112929Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-07-19
10889950114046Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-06-27