FDA.reportPublic FDA data

M.A.R.A.

Primary DI
00889989074666
Brand
M.A.R.A.
Company
ORMCO CORPORATION
Model
600-3000
Device description
M.A.R.A. KIT Mandibular Anterior Repositioning Appliance
Published
2024-03-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989074666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989074666008899890746668899890746660889989074666

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic rod-based alignerAn orthodontic device which includes a rod(s) intended to be bonded to teeth to correct malocclusions (e.g., overbites); it is commonly known as Herbst appliance. The rod, also referred to as a piston or tube, is typically positioned with a metal band and/or bracket and incorporates a hinge-like mechanism to allow jaw opening/closing. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags#

DUNS number
154614119
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08
10889989088882Ormco™ EtchFree Bonding740-05002025-05-09
00889989088892Ormco™ EtchFree Bonding740-05102025-05-09
00889989088908Ormco™ EtchFree Bonding740-05202025-05-09
10889989088912Ormco™ EtchFree Bonding740-05252025-05-09
10889989012252Straight-Wire Synthesis338-03102024-03-07
10889989012269Straight-Wire Synthesis338-03112024-03-07
10889989012276Straight-Wire Synthesis338-04102024-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611205742TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x0.76MM - 25UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
07908611205759TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
00815967029380RodinPac-Dent, Inc.KMY2026-03-23
00815967029397RodinPac-Dent, Inc.KMY2026-03-23
06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422563Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422570Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422587Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423065Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
03770020010163FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010187FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
D775JAGFP0AccuguardGreat Lakes Dental Technologies, Ltd.KMY2026-01-16
28906139321169Taglus UltraLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321466Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321473Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321480Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321497Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321527Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321695Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321718Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321749Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321756Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321824Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321831Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321855Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321879Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09