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 Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin Composite R363S 113 Straight Serrated Cord Packer R375 Mixing Spatula/Applicator R386 38-39 Excavator T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T040 Tweezers COLLEGE T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T319 Bur Block T800 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
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

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

Regulatory Flags#

DUNS number
125850144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
06438311708775LMDentalLM-DentalDZN2026-05-25
06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
00348783008807Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783008890Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009552Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009569Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00840479202594RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
10840481136013BULK EZZest Anchors, LLCDZN2026-03-10
00840479201054COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201078COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201085COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27