FDA.report

Inspire ICE

Primary DI
00889989080995
Brand
Inspire ICE
Company
ORMCO CORPORATION
Model
443-2211
Device description
U2L INSPIRE ICE MCLAUGHLIN, BENNETT & TREVISI .018 +10/8/0
Published
2017-12-14
Public version status
Update
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

Contact Domains

Product Codes

CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889989080995PrimaryGS10
10889989080992Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989080995008899890809958899890809950889989080995
1088998908099210889989080992

GMDN Terms

TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags

DUNS number
154614119
Device count
5
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
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 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

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00190746198502Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198519Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198526Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198533Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198540Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198557Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198564Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198571Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198588Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198595Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198601Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198618Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198625Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198632Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198649Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23