FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677021847
Brand
PDT, Inc.
Company
PDT, INC.
Model
R348 Plugger 1/2
Catalog number
R348
Published
2021-04-30
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

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
00813677021847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677021847008136770218478136770218470813677021847

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125850144
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025319PDT, Inc.T804 Beebee Crown Curved Scissors (10.5cm)T8052025-09-03
00813677025258PDT, Inc.AU026 Gracey 11/12AU0262025-08-14
00813677025265PDT, Inc.AU028 Gracey 13-14AU0282025-08-14
00813677025272PDT, Inc.AU061 Barnhart 5-6AU0612025-08-14
00813677025289PDT, Inc.AU110 H6-7AU1102025-08-14
00813677025296PDT, Inc.AU135 204SAU1352025-08-14
00813677025302PDT, Inc.AU138 Ouback JackAU1382025-08-14
00813677023018PDT, Inc.T315 Millimeter RulerT3152025-05-12
00813677025241PDT, Inc.R218 Montana Precision ProbeR2182025-05-07
00813677025234PDT, Inc.R245-M Mirror Handle (Cone-Socket)-Missions R245-M2025-04-23
00813677025210PDT, Inc.R908 - PDT Demo Wallet 3 Pack - HygieneR9082025-03-25
00813677025227PDT, Inc.R909 - PDT Wallet 3 Pack - DoctorR9092025-03-25
00813677025197PDT, Inc.R138-25 25th Anniversary Montana Jack®R138-252025-02-20
00813677025180PDT, Inc.R960 2024 Advent CalendarR9602024-11-27
00813677025173PDT, Inc.R960 2024 Advent CalendarR9602024-11-06
00813677024138PDT, Inc.T018FM Silicone Finger MatT018FM2024-10-16
00813677025159PDT, Inc.R338 21B-27 BurnisherR3382024-09-11
00813677025166PDT, Inc.R528 CSS-7 Composite SystemR5282024-09-11
00813677025142PDT, Inc.R985 Rev B Andy RDH Student KitsR983 Rev C2024-08-29
00813677025135PDT, Inc.R983 Rev C Basic Extraction KitR983 Rev C2024-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018672307Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-11
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00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
00840018662506Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
00889813065952Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065969Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065983Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065990Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066003Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066027Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066034Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066010Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-10-01
00842517118553Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118560Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118577Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118584Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118591Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075604675OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609670OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609717OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04