FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024985
Brand
PDT, Inc.
Company
PDT, INC.
Model
R943 PDT Endo Kit
Catalog number
R943
Device description
"Kit Includes:(T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider(R245) Cone Socket Mirror Handle(R311) DG 16 Explorer(R312) D11 Endo Spreader(R314) 1-3 Endo Plugger(R315) 5-7 Endo Plugger(R316) 9-11 Endo Plugger(R317) Glick 1(R318) 31L Endo Excavator(T046) Miller Articulating Paper Forceps(T047) Endo Locking Pliers(T050) #5 Mirror (15/16"")(T235) Aspirating Anesthetic Syringe Medium(T784) Ainsworth Rubber Dam Punch Forceps(T785) Ivory Rubber Dam Clamp Forceps(T786) Rubber Dam Frame(T863) Small Parts Basket"
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
EJEFrame, Rubber Dam
EJGForceps, Rubber Dam Clamp
EKBExplorer, Operative
EKCExcavator, Dental, Operative
EKKSpreader, Pulp Canal Filling Material, Endodontic
EKRPlugger, Root Canal, Endodontic
FSMTray, Surgical, Instrument
MXPBone Particle Collector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EJBHandle, Instrument, DentalDental1
EJEFrame, Rubber DamDental1
EJGForceps, Rubber Dam ClampDental1
EKBExplorer, OperativeDental1
EKCExcavator, Dental, OperativeDental1
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1
EKRPlugger, Root Canal, EndodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
MXPBone Particle CollectorEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024985008136770249858136770249850813677024985

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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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