ORTHO ORGANIZERS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2081322	2081322	ORTHO ORGANIZERS, INC.	1	Y	2026-01-01	800 King George Blvd, Suite 100 Savannah GA US 31419

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5364	1302654093	K980195	FACEBOW	DZB	1998-03-11
5364	1536529311	K980151	RELEASABLE FORCE MODULE	DZB	1998-04-06
5364	1136253979	K973776	REFLECTIONS	DYW	1997-11-21
5364	1607155727	K961754	SAFETY RELEASE MODULE	DZB	1996-07-10
5364	1372489866	K942742	ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV	DYH	1994-08-29
5364	1896225750	K940410	NEW GEAR RELEASABLE HEADGEAR	DZB	1994-03-10
5364	1718467214	K940120	ALPHA-DENT	ELW	1994-02-25
5364	1971401981	K935625	ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE	DYH	1994-08-10
5364	1563949504	K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	EJF	1992-07-30
5364	1832927178	K823510	CURAY ANTERIOR/POSTERIOR RESTORATIVE	EBF	1982-12-28
5364	1251778339	K252760	Carriere® Motion Pro® Clear Bite Corrector	DYW	2025-11-27
5364	1982035982	K210613	HIT Clear Aligner	NXC	2021-06-04
5364	1668442793	K202857	ClearPath Aligner	NXC	2021-01-05
5364	1675577073	K173440	Carriere SLX 3D Clear	NJM	2018-03-08
5364	1725977429	K160720	Carriere Motion Clear Class II	DYW	2016-11-28
5364	1273261478	K110335	CERAMIC BRACKETS	NJM	2011-05-19
5364	1021316534	K073045	SAPPHIRE CERAMIC BRACKET	NJM	2007-12-18
5364	1557998339	K000358	MULTI ADJUSTABLE FACE MASK	DZB	2000-06-09
5364	1365454283
5364	1478783858
5364	1730757588
5364	1035211958
5364	1059243323
5364	1101455100
5364	1127871122
5364	1131830928
5364	1174480252
5364	1205378712
5364	1264188943
5364	1266156267
5364	1299566942
5364	1349880783
5364	1413834851
5364	1424677934
5364	1459708370
5364	1524196162
5364	1531862560
5364	1534650810
5364	1599458015
5364	1632628848
5364	1644661022
5364	1693660466
5364	1749961146
5364	1769988434
5364	1777299344
5364	1842551734
5364	1941763290
5364	1944457818
5364	2012632018
5364	2013930310
5364	2018933304
5364	2033822052
5364	2047575444
5364	2053957712
5364	2069582615

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DZB	5	2000-06-09
DYW	4	2025-11-27
NJM	3	2018-03-08
NXC	2	2021-06-04
DYH	2	1994-08-29
ELW	2	1994-02-25
EJF	1	1992-07-30
EBF	1	1982-12-28

PMN#

Carriere® Motion Pro® Clear Bite Corrector
2025-11-27
Ortho Organizers, Inc.
Carriere SLX 3D Clear
2018-03-08
Ortho Organizers, Inc.
Carriere Motion Clear Class II
2016-11-28
ORTHO ORGANIZERS, INC.
CERAMIC BRACKETS
2011-05-19
ORTHO ORGANIZERS, INC.
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
2006-07-31
ORTHO ORGANIZERS, INC.
NITANIUM PALATAL EXPANDER
1993-09-13
ORTHO ORGANIZERS, INC.
STAINLESS STEEL ORTHODONTIC PRODUCTS
1993-09-01
ORTHO ORGANIZERS, INC.
NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
1993-07-08
ORTHO ORGANIZERS, INC.

GUDID#

Aria® Expressions® - Aria® Expressions® .022 Roth UR1 +12T 5A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UL1 +12T 5A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UR2 +8T 9A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UL2 +8T 9A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022Roth 1/2 LL/R -1T 0A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UR3 HK -2T 13A 4MO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UL3 HK -2T 13A 4MO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UR4/5 HK -7T 0A 2DO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth UL 4/5 HK -7T 0A 2DO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LR3 HK -11T 7A 2MO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LL3 HK -11T 7A 2MO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LR4 HK -12T 2A 0O (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LL4 HK -17T 0A 4DO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LR5 HK -22T 0A 4DO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth LL5 HK -22T 0A 4DO (10)
Ortho Organizers, Inc.
2026-08-27
Aria® Expressions® - Aria® Expressions® .022 Roth Kit U/L 5x5 HK 3/4/5
Ortho Organizers, Inc.
2026-08-27
Endura Plus Instruments - Endura® Plus™ Mathieu Narrow Tip
Ortho Organizers, Inc.
2020-07-13
Envision - Envision .018 UR1 12T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL1 12T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UR2 8T 9A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL2 8T 9A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR 1/2 0T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LL 1/2 0T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UR3 0T 11A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL3 0T 11A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UR3 HK 0T 11A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL3 HK 0T 11A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UR 4/5 -7T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL 4/5 -7T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UR 4/5 HK -7T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 UL 4/5 HK -7T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR3 -11T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LL3 -11T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR3 HK -11T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LL3 HK -11T 5A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR4 -17T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LL4 -17T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR4 HK -17T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LL4 HK -17T 0A 0O
Ortho Organizers, Inc.
2016-09-24
Envision - Envision .018 LR5 -22T 0A 0O
Ortho Organizers, Inc.
2016-09-24

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