FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677023544
Brand
PDT, Inc.
Company
PDT, INC.
Model
T830 Vertical Crown Remover
Catalog number
T830
Device description
T830 Vertical Crown Remover
Published
2024-07-01
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
EISRemover, Crown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677023544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677023544008136770235448136770235440813677023544

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis removal instrumentA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat 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
true
Serial number
false
Manufacturing date on label
true
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
G14934001F08TBS DentalACME ENTERPRISE.EIS2026-03-02
04963931210794NAYDM CORPORATIONEIS2025-12-05
04963931210800NAYDM CORPORATIONEIS2025-12-05
00841336106086Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108646Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336108660Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2025-11-11
00841336100916Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125551Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125568Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
00841336125599Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIS2024-12-11
06974456210815CICADAFoshan Cicada Dental Instrument Co., Ltd.EIS2024-08-10
00813677025098PDT, Inc.PDT, INC.EIS2024-07-03
00813677023292PDT, Inc.PDT, INC.EIS2024-07-02
00813677024565PDT, Inc.PDT, INC.EIS2024-07-02
00813677023285PDT, Inc.PDT, INC.EIS2024-07-01
00813677023551PDT, Inc.PDT, INC.EIS2024-07-01
D105SKU1311760SurgiMac Surgimac LLCEIS2024-05-10
00842517107366Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-18
00842517107458Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-18
00842517107328Karl SchumacherKarl Schumacher Dental, LLCEIS2024-03-01
00842517107373Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107397Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107403Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107410Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107427Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107441Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107465Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27
00842517107472Karl SchumacherKarl Schumacher Dental, LLCEIS2024-02-27