FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813040201
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9581078
Catalog number
9581078
Device description
PROBE SE #11
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00889813040201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813040201008898130402018898130402010889813040201

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

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
10889813067960Darby Dental Supply, LLC95531292025-07-12
10889813067649Darby Dental Supply, LLC52584552025-07-02
10889813067663Darby Dental Supply, LLC95531332025-07-02
10889813067670Darby Dental Supply, LLC95531342025-07-02
10889813067687Darby Dental Supply, LLC95531352025-07-02
10889813067694Darby Dental Supply, LLC95531362025-07-02
10889813067700Darby Dental Supply, LLC95531372025-07-02
10889813067717Darby Dental Supply, LLC95531392025-07-02
10889813067724Darby Dental Supply, LLC95531382025-07-02
10889813067731Darby Dental Supply, LLC95531402025-07-02
10889813067755Darby Dental Supply, LLC95531412025-07-02
10889813067762Darby Dental Supply, LLC95531422025-07-02
10889813067779Darby Dental Supply, LLC95531432025-07-02
10889813067786Darby Dental Supply, LLC95531442025-07-02
10889813067793Darby Dental Supply, LLC95531452025-07-02
10889813067809Darby Dental Supply, LLC95531462025-07-02
10889813067816Darby Dental Supply, LLC95531472025-07-02
10889813067823Darby Dental Supply, LLC95531482025-07-02

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