FDA.reportPublic FDA data

YC3 Shield

Primary DI
00190746075889
Brand
YC3 Shield
Company
AMERICAN ORTHODONTICS CORPORATION
Model
855-711M
Catalog number
855-711M
Device description
YC3 CLASS III MIXED DENTITION APPLIANCE MIXED DENTITION
Published
2020-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BRWProtector, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746075889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746075889001907460758891907460758890190746075889

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance system, adjustableAn assembly of devices such as metal bands, archwires, springs and/or power arms, designed to influence the shape and/or function of the stomatognathic system. Once applied to the teeth, it may be periodically adjusted to effect skeletal and/or dental changes by modifying and utilizing the neuromuscular forces of the stomatognathic system. It is typically used to correct malocclusions such as underbites, overbites, and cross bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. Commonly known as a dental brace or orthodontic brace, it is a single-patient device that is 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746150012Superelastic Titanium Memory857-54138TQSPW857-54138TQSPW2019-08-12
00190746150029Superelastic Titanium Memory857-54234TQSPW857-54234TQSPW2019-08-12
00190746150036Superelastic Titanium Memory857-54238TQSPW857-54238TQSPW2019-08-12
00190746150098Superelastic Titanium Memory857-551TQSPW857-551TQSPW2019-08-12
00190746150104Superelastic Titanium Memory857-552TQSPW857-552TQSPW2019-08-12
00190746150128Superelastic Titanium Memory857-554TQSPW857-554TQSPW2019-08-12
00190746148354Superelastic Titanium Memory857-731W857-731W2019-08-09
00190746007835Procelain Conditioner001-966001-9662016-11-09
00190746133282Rapid Molar Intruder852-202852-2022018-07-05
00190746133299Rapid Molar Intruder852-203852-2032018-07-05
00190746096112MasterSeries390-8712B390-8712B2018-08-03
00190746096334MasterSeries390-8713B390-8713B2018-08-03
00190746097904MasterSeries390-8716B390-8716B2018-08-03
00190746098093MasterSeries390-8717B390-8717B2018-08-03
00190746203770Weldable Cleat852-166852-1662026-04-21
00190746203787Weldable Cleat852-166PK852-166PK2026-04-21
00190746203794Weldable Cleat852-168PK852-168PK2026-04-21
00190746203800Weldable Cleat852-168852-1682026-04-21
00190746203817Weldable Cleat852-167PK852-167PK2026-04-21
00190746203824Weldable Cleat852-167852-1672026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbHBRW2026-04-27
08800017902289EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017901817EZ Bite blockDXM CO., LTDBRW2025-12-16
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797099365RMORmo, Inc.BRW2024-09-02
00885797099372RMORmo, Inc.BRW2024-09-02
00885797099396RMORmo, Inc.BRW2024-09-02
00885797099402RMORmo, Inc.BRW2024-09-02
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
00630094199702Bioseal Inc.BIOSEALBRW2023-12-12
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
00630094199207Bioseal Inc.BIOSEALBRW2023-12-11
00630094199252Bioseal Inc.BIOSEALBRW2023-12-11
00630094199306Bioseal Inc.BIOSEALBRW2023-12-11
00630094199320Bioseal Inc.BIOSEALBRW2023-12-11
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11