FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105207436
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
OPHOE-22
Device description
#22
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
EMQHOE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMQHoe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105207436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105207436008401052074368401052074360840105207436

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal hoeA hand-held manual dental instrument with a small blade at an acute angle (e.g., 90 degrees) to its stem intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. It is usually made of high-grade stainless steel. 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
00840018661318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMQ2026-01-28
D928400512RD0CHISEL 7-10 D/E ROUND HANDLEW.H. Holden, Inc.EMQ2026-01-06
10889950133603Hu-FriedyHU-FRIEDY MFG. CO., LLCEMQ2025-12-19
00841336108738Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMQ2025-11-11
00841013116513American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
00841013116537American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
10889950023102Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950025526Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950092887Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950093693Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950023096Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950023294Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025489Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025496Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025588Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025595Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030636Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030643Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030650Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030667Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033194Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033200Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033361Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033378Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950089863Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950091897Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092764Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092849Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092979Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950096922Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07