FDA.report

Health-Tec/DHP 3-in-1 Bite Impression Trays

Primary DI
D773310HT0041
Brand
Health-Tec/DHP 3-in-1 Bite Impression Trays
Company
Dental Health Products Inc
Model
310-HT004
Catalog number
310-HT004
Device description
Health-Tec/DHP 3-in-1 Bite Impression Trays Quadrant 35/bag
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHYTray, Impression, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773310HT0041PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
623191194
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D7735901000721DHP/Health-Tec Sterilization Tape 590-100072590-1000722023-03-24
D7735901000821DHP/Health-Tec Sterilization Tape590-100082590-1000822023-03-24
D7736001000320DHP/Health-Tec Sterilization Pouches600-100032600-1000322023-03-23
D7736001000420DHP/Health-Tec Sterilization Pouches600-100042600-1000422023-03-23
D7736001000520DHP/Health-Tec Sterilization Pouches600-100052600-1000522023-03-23
D7736001000620DHP/Health-Tec Sterilization Pouches600-100062600-1000622023-03-23
D7736001000720DHP/Health-Tec Sterilization Pouches600-100072600-1000722023-03-23
D7736001000820DHP/Health-Tec Sterilization Pouches600-100082600-1000822023-03-23
D7736001000920DHP/Health-Tec Sterilization Pouches600-100092600-1000922023-03-23
D7736001001020DHP/Health-Tec Sterilization Pouches600-100102600-1001022023-03-23
D7736001001120DHP/Health-Tec Sterilization Pouches600-100112600-1001122023-03-23
D773970100010Health-Tec/DHP Disposable Prophy Angles970-10001970-100012022-11-28
D773970100020Health-Tec/DHP Disposable Prophy Angles970-10002970-100022022-11-28
D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
D7739705224140Health-Tec/DHP Disposable Prophy Angles970-522414970-5224142022-11-28
D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
D773930100060Health-Tec/DHP PSP Barrier Envelopes930-10006930-100062022-11-14
D773930HTBWT0Health-Tec/DHP Bite Wing Tabs930-HTBWT930-HTBWT2022-11-14
D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
E241VT0220Cavex Bleach Transparent 1,0 mmCavex Holland B.V.EHY2026-03-10
28906139322081Taglus Impression TrayLAXMI DENTAL LIMITEDEHY2026-01-09
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/PackPRACTICON, INC.EHY2026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/PackPRACTICON, INC.EHY2026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/PackPRACTICON, INC.EHY2026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/PackPRACTICON, INC.EHY2026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/PackPRACTICON, INC.EHY2026-01-08
00817169023890Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHY2025-12-16
06977979289856AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447935008AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
06978447938504AiditeAidite (Qinhuangdao) Technology Co., Ltd.EHY2025-11-17
10190707193192Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707193208Redi-Lock™Ortho Organizers, Inc.EHY2025-10-23
10190707110786DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110793DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110809DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110816DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110823DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110830DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110847DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110854DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110861DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110878DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25
10190707110885DuraLock®ORTHO ORGANIZERS, INC.EHY2025-09-25