FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105207825
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
OPPLG-BLK-1S/2S
Device description
Black #1S/2S (Serrated)
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105207825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105207825008401052078258401052078250840105207825

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

Regulatory Flags#

DUNS number
005449822
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840105223009ZOLL DENTALSYR-4962-22023-07-11
00840105223818ZOLL DENTALZ-49342025-09-16
00840105223825ZOLL DENTALZ-49362025-09-16
00840105223832ZOLL DENTALZ-49372025-09-16
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
00840105215226ZOLL-DENTALZ-10TKP2021-03-10
00840105215714ZOLL-DENTALZ-11TKP2021-03-10
00840105215967ZOLL-DENTALZ-12TKP2021-03-10
00840105216131ZOLL-DENTALZ-19-274-13-P2021-03-10
00840105216148ZOLL-DENTALZ-19-274-13-T2021-03-10
00840105216155ZOLL-DENTALZ-19-274-162021-03-10
00840105218388ZOLL-DENTALZ-44382021-03-10
00840105220268ZOLL-DENTALZ-71451-002021-03-10
00840105220275ZOLL-DENTALZ-71451-012021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4160TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4170TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4180TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
00348783012323Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKG2026-04-30
10889950147242Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147259Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147266Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147273Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147280Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147297Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147303Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147310Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147327Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147334Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147341Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147358Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147365Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147686Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147785Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147839Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147853Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147860Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147877Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148447Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148454Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
07898506843541QuinelatoSchobell Industrial LtdaEKG2022-12-08
07898506843657QuinelatoSchobell Industrial LtdaEKG2022-12-08
07899798200029QuinelatoSchobell Industrial LtdaEKG2022-12-08
10889950019129HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKG2020-11-12