FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024480
Brand
PDT, Inc.
Company
PDT, INC.
Model
R982 Endo Kit
Catalog number
R982
Device description
Kit Includes:T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std DividerR245 Mirror Handle (Cone-Socket)R311 DG 16 ExplorerR312 D11 Endo SpreaderR314 1/3 Endo PluggerR315 5/7 Endo PluggerR316 9/11 Endo PluggerR317 Glick 1R318 31L Endo ExcavatorT045 Locking Cotton PlierT046 Articulating paper forceps MILLERT050 #5 Front Surface Mirror, Cone-Socket, (15/16')T235 Aspirating Anesthetic Syringe MediumT785 Rubberdam clamp forceps IVORY
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAXMirror, Mouth
EICSyringe, Periodontic, Endodontic, Irrigating
EJBHandle, Instrument, Dental
EJGForceps, Rubber Dam Clamp
EKBExplorer, Operative
EKCExcavator, Dental, Operative
EKKSpreader, Pulp Canal Filling Material, Endodontic
EKRPlugger, Root Canal, Endodontic
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EJBHandle, Instrument, DentalDental1
EJGForceps, Rubber Dam ClampDental1
EKBExplorer, OperativeDental1
EKCExcavator, Dental, OperativeDental1
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1
EKRPlugger, Root Canal, EndodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024480008136770244808136770244800813677024480

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025395PDT, Inc.R117 Boge Precision DuoR1172026-05-12
00813677025388PDT, Inc.R098MB R098MB2026-04-27
00813677023230PDT, Inc.T732 Stieglitz 30° Splinter ForcepT7322024-07-02
00813677025364PDT, Inc.T055-3 Double-Sided PrecisionReflect HD Mirror ThrT055-32025-10-20
00813677025371PDT, Inc.T055-6 Double-Sided PrecisionReflect HD Mirror TweT055-62025-10-20
00813677025326PDT, Inc."T050-3 #5 PrecisionReflect HD Mirror (15/16"") ThT050-32025-10-16
00813677025333PDT, Inc."T050-12 #5 PrecisionReflect HD Mirror (15/16"") TT050-122025-10-16
00813677025340PDT, Inc."T051-3 #4 PrecisionReflect HD Mirror (7/8"") ThreT051-32025-10-16
00813677025357PDT, Inc."T051-12 #4 PrecisionReflect HD Mirror (7/8"") ThrT051-122025-10-16
00813677025319PDT, Inc.T805 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
00813677022455PDT, Inc.T044 Titanium TweezersT0442024-07-05
00813677023612PDT, Inc.T845 Bone Carrier (3.5mm)T8452024-07-02
00813677023629PDT, Inc.T846 Bone Carrier (4.5mm)T8462024-07-02
00813677023636PDT, Inc.T847 Bone Carrier (6mm)T8472024-07-02

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