FDA.reportPublic FDA data

Norm-O Orthodontic Tray

Primary DI
00192029043769
Brand
Norm-O Orthodontic Tray
Company
TP ORTHODONTICS INC
Model
179-014
Device description
Teflon Coated Perforated
Published
2021-03-15
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
true

Product Codes#

Code, Name table
CodeName
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192029043769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029043769001920290437691920290437690192029043769

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005432299
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
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
00192029050538Tip-Edge PLUS Stainless Steel Brackets296-61122025-02-04
00192029050545Tip-Edge PLUS Stainless Steel Brackets296-61222025-02-04
00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
00192029050569Tip-Edge PLUS Stainless Steel Brackets296-61422025-02-04
00192029050576Tip-Edge PLUS Stainless Steel Brackets296-61522025-02-04
00192029050583Tip-Edge PLUS Stainless Steel Brackets296-61622025-02-04
00192029050590Tip-Edge PLUS Stainless Steel Brackets296-61722025-02-04
00192029050606Tip-Edge PLUS Stainless Steel Brackets296-61822025-02-04
00192029050613Tip-Edge PLUS Stainless Steel Brackets296-61922025-02-04
00192029050620Tip-Edge PLUS Stainless Steel Brackets296-62022025-02-04
00192029050637Tip-Edge PLUS Stainless Steel Brackets296-62322025-02-04
00192029050644Tip-Edge PLUS Stainless Steel Brackets296-62422025-02-04
00192029050651Tip-Edge PLUS Stainless Steel Brackets296-62522025-02-04
00192029050668Tip-Edge PLUS Stainless Steel Brackets296-62622025-02-04
00192029050675Tip-Edge PLUS Stainless Steel Brackets296-62922025-02-04
00192029050682Tip-Edge PLUS Stainless Steel Brackets296-63022025-02-04
00192029050699Tip-Edge PLUS Stainless Steel Brackets296-63122025-02-04
00192029050705Tip-Edge PLUS Stainless Steel Brackets296-63222025-02-04
00192029050712Tip-Edge PLUS Stainless Steel Brackets296-63322025-02-04
00192029050729Tip-Edge PLUS Stainless Steel Brackets296-63422025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
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