FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024466
Brand
PDT, Inc.
Company
PDT, INC.
Model
R980 Crown and Bridge Kit
Catalog number
R980
Device description
Kit Includes:T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std DividerR138R Montana Jack® RigidR166 Explorer 5R215 Probe WRS ACE™-UNC12R245 Mirror Handle (Cone-Socket)R286 G2 Thin CompositeR363S 113 Straight Serrated Cord PackerR375 Mixing Spatula/ApplicatorR386 38-39 ExcavatorT050 #5 Front Surface Mirror, Cone-Socket, (15/16')T040 Tweezers COLLEGET046 Articulating paper forceps MILLERT235 Aspirating Anesthetic Syringe MediumT319 Bur BlockT800 IRIS Scissors, curved
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
DZNInstruments, Dental Hand
EAXMirror, Mouth
EGNScissors, Surgical Tissue, Dental
EICSyringe, Periodontic, Endodontic, Irrigating
EIXProbe, Periodontic
EJBHandle, Instrument, Dental
EJYPliers, Operative
EKBExplorer, Operative
EKCExcavator, Dental, Operative
EKHCarver, Dental Amalgam, Operative
EMNScaler, Periodontic
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
EAXMirror, MouthDental1
EGNScissors, Surgical Tissue, DentalDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EIXProbe, PeriodonticDental1
EJBHandle, Instrument, DentalDental1
EJYPliers, OperativeDental1
EKBExplorer, OperativeDental1
EKCExcavator, Dental, OperativeDental1
EKHCarver, Dental Amalgam, OperativeDental1
EMNScaler, PeriodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024466008136770244668136770244660813677024466

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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