FDA.reportPublic FDA data

Cleo

Primary DI
00190746064449
Brand
Cleo
Company
AMERICAN ORTHODONTICS CORPORATION
Model
002-22-000010HD
Catalog number
002-22-000010HD
Device description
COSMETIC CLEO UL BIC 022 T-7 A=0 R=0 W/HK DIST
Published
2025-01-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJMBracket, ceramic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232011000CleoAmerican Orthodontics2023-07-07NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746064449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746064449001907460644491907460644490190746064449

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746062896BracePaste Fluoride Sealant Kit020-039668020-0396682024-10-28
00190746188800BracePaste Fluoride Sealant020-035993020-0359932024-10-10
00190746059193BracePaste020-026877020-0268772022-10-05
00190746059209BracePaste020-026878020-0268782022-10-05
00190746059216BracePaste020-026879020-0268792022-10-05
00190746059223BracePaste020-026880020-0268802022-10-05
00190746059254BracePaste MTP Light Cure Primer020-029614020-0296142022-10-05
00190746059261BracePaste MTP Kit020-030089020-0300892022-10-05
00190746059285BracePaste020-031573020-0315732022-10-05
00190746059292BracePaste020-031574020-0315742022-10-05
00190746059322BracePaste020-031575020-0315752022-10-05
00190746059339Bracepaste Band and Build LC020-032026020-0320262022-10-05
00190746059346Bracepaste Band and Build LC020-032027020-0320272022-10-05
00190746059476Carbide BurFG118LFG118L2022-10-05
00190746059506Carbide BurFG118SFG118S2022-10-05
00190746059513Carbide BurFG218FG2182022-10-05
00190746059520Carbide BurFG283-014FG283-0142022-10-05
00190746059551Diamond BurFG392-016FFG392-016F2022-10-05
00190746059568Carbide BurFG699LFG699L2022-10-05
00190746059575Carbide BurFG7675FG76752022-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210067PROMO KIT ICERAM-P ROTH 0.022ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2024-04-16
07895742282103MorelliDental Morelli LtdaNJM2023-11-14
07895742282110MorelliDental Morelli LtdaNJM2023-11-14
07895742282127MorelliDental Morelli LtdaNJM2023-11-14
07895742282134MorelliDental Morelli LtdaNJM2023-11-14
07895742282141MorelliDental Morelli LtdaNJM2023-11-14
07895742282158MorelliDental Morelli LtdaNJM2023-11-14
07895742282165MorelliDental Morelli LtdaNJM2023-11-14
07895742282172MorelliDental Morelli LtdaNJM2023-11-14
07895742282189MorelliDental Morelli LtdaNJM2023-11-14
07895742282196MorelliDental Morelli LtdaNJM2023-11-14
07895742282202MorelliDental Morelli LtdaNJM2023-11-14
07895742282219MorelliDental Morelli LtdaNJM2023-11-14
07895742282226MorelliDental Morelli LtdaNJM2023-11-14
08800046016025VAR-18-301GNI Co.,LtdNJM2022-12-14
08800046016032VAR-18-331GNI Co.,LtdNJM2022-12-14
08800046016049VAR-18-051GNI Co.,LtdNJM2022-12-14
08800046016056VAR-18-501GNI Co.,LtdNJM2022-12-14
08800046016063VAR-18-551GNI Co.,LtdNJM2022-12-14
08800046016070VAR-18-053GNI Co.,LtdNJM2022-12-14
08800046016087VAR-18-503GNI Co.,LtdNJM2022-12-14
08800046016094VAR-18-553GNI Co.,LtdNJM2022-12-14
08800046016100VAR-22-031GNI Co.,LtdNJM2022-12-14
08800046016117VAR-22-301GNI Co.,LtdNJM2022-12-14
08800046016124VAR-22-331GNI Co.,LtdNJM2022-12-14
08800046016131VAR-22-051GNI Co.,LtdNJM2022-12-14
08800046016148VAR-22-501GNI Co.,LtdNJM2022-12-14
08800046016155VAR-22-551GNI Co.,LtdNJM2022-12-14
08800046016162VAR-22-053GNI Co.,LtdNJM2022-12-14
08800046016179VAR-22-503GNI Co.,LtdNJM2022-12-14