FDA.reportPublic FDA data

Therma Cure

Primary DI
D798TC0
Brand
Therma Cure
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
TC
Catalog number
TC
Device description
Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.
Published
2016-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071590000THERMA-CUREReliance Orthodontic Products, Inc.2007-07-31DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798TC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature (15-30 degrees C.)

Contacts#

Phone, Email table
PhoneEmail
630-773-4009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06
D798LBTPP0Light BondLBTPPLBTPP2019-01-14
D798MC20AF0Maximum CureMC20AFMC20AF2016-08-10
D798OFT20Ortho FlexTechOFT2OFT22016-08-06
D798OFTSAM0Ortho FlexTechOFTOFT2018-04-13
D798PO0Porcelain ConditionerPOPO2016-08-15
D798PPA20Perfect A SmilePPA2PPA22016-08-06
D798RSPFG1RenewRSPFGRSPFG2016-09-04
D798UBLBPP0Ultra Band LokUBLBPPUBLBPP2016-07-25
D798UBLPP0Ultra Band LokUBLPPUBLPP2016-07-25
D7981FTLV0Flow Tain1FTLV1FTLV2020-07-19
D7981LLUBLBP0Ultra Band Lok1LLUBLBP1LLUBLBP2020-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006522210868083M™ Unitek™ Metal Brackets3M UNITEK CORPORATIONDYH2026-05-07
006522212281543M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212282223M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282533M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282603M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282913M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283073M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283763M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284063M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284133M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212998263M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998333M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998403M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998573M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998643M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998713M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998883M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998953M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522213074393M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
006522213074463M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
00190746061318No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061325No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061332No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061370Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061394Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061400Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061417Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061431Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061455Porcelain ConditionerAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061516MR Lock LCAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10