FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105209379
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
PCC-11
Device description
PCC-11
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
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105209379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105209379008401052093798401052093790840105209379

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal probe, reusableA hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). 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
G149NPPEXP0NPSACME ENTERPRISE.EIX2026-05-01
00348783006438Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006629Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006766Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006780Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006803Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006810Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006827Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006841Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00840018674516Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-03-12
B382SD502210Surgical DirectSurgical Direct, Inc.EIX2026-02-26
00840018674097Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-11
00840018667051Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667143Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667792Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018666498Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
00840018666597Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
B382SD12240Surgical DirectSurgical Direct, Inc.EIX2026-02-04
B382SD923898000Surgical DirectSurgical Direct, Inc.EIX2026-02-04
00840018662582Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018663268Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018661646Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-28
00841013120473Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EIX2026-01-06
D9284002151M0PERIO PROBE MARQUIS STYLE #1 CC 3-6-9-12W.H. Holden, Inc.EIX2026-01-06
00841336100985Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIX2025-11-11
B382SD9252232010Surgical DirectSurgical Direct, Inc.EIX2025-09-18
B382SD49400Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD936091010Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD93770610810Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD9377061100Surgical DirectSurgical Direct, Inc.EIX2025-08-07