FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677025142
Brand
PDT, Inc.
Company
PDT, INC.
Model
R985 Rev B Andy RDH Student Kits
Catalog number
R983 Rev C
Device description
Kit Includes:R026 Amazing Gracey™ 11-12R028 Amazing Gracey™ 13-14R061 Barnhart 5-6R093 N128-L5 MiniR096 N1R130S Jack B. Nimble® Slim ScalerR135 204SR138 Montana Jack®R166 Explorer 5R167 Explorer ODU 11-12R215 Probe WRS ACE™-UNC12R245 Mirror Handle (Cone-Socket)T009D-F15 FlipTop™ Cassette 'D' - Fixed Rack 15 T055 Double-Sided PrecisionReflect HD
Published
2024-08-29
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
EIXProbe, Periodontic
EJBHandle, Instrument, Dental
EKBExplorer, Operative
EMNScaler, Periodontic
EMSCurette, Periodontic
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EIXProbe, PeriodonticDental1
EJBHandle, Instrument, DentalDental1
EKBExplorer, OperativeDental1
EMNScaler, PeriodonticDental1
EMSCurette, PeriodonticDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677025142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677025142008136770251428136770251420813677025142

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
ESAM14621761STOMA®Storz am Mark GmbHEMS2025-04-30
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM13322071STOMA®Storz am Mark GmbHEJB2023-06-13
EMICCHFF251Enamel Plus Hri FLOWMICERIUM SPAEJB2023-05-05
EMICES61Ena ShinyMICERIUM SPAEJB2023-05-05
EMICTPENMP1Enamel Plus Stain & InstrumentsMICERIUM SPAEJB2023-05-05
EMICTRAG1Enamel Plus Stain & InstrumentsMICERIUM SPAEJB2023-05-05
EMICTRAW1Enamel Plus Stain & InstrumentsMICERIUM SPAEJB2023-05-05
ESAM14627201STOMA®Storz am Mark GmbHEMS2023-01-24
ESAM14627301STOMA®Storz am Mark GmbHEMS2022-11-07
ESAM6939081STOMA®Storz am Mark GmbHFSM2022-11-07
EMICCOSM3T1Ena ®MICERIUM SPAEJB2021-12-09
ESAM14621651STOMA®Storz am Mark GmbHEMS2020-11-09
ESAM14621751STOMA®Storz am Mark GmbHEMS2020-11-09
ESAM14621801STOMA®Storz am Mark GmbHEMS2020-11-09
04056481122751Sterilization Tray Standards Cranial AccessoriesBrainlab SEFSM2020-10-21
04056481122867Sterilization Tray Frameless Biopsy SystemBrainlab SEFSM2020-10-21
04056481122874Sterilization Tray VarioguideBrainlab SEFSM2020-10-21
ESAM12718001STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12718101STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12720101STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12721001STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12721101STOMA®Storz am Mark GmbHEMN2020-08-27