FDA.reportPublic FDA data

Silkon Plus

Primary DI
00190746003875
Brand
Silkon Plus
Company
AMERICAN ORTHODONTICS CORPORATION
Model
002-967M
Catalog number
002-967M
Device description
COSMETIC SILKON LL CUSP 018 T+5 A+10 R=0
Published
2016-11-09
Public version status
Update
Distribution status
Not 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
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K891372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K891372000ORTHODONTIC PLASTIC BRACKETAmerican Orthodontics1989-03-31DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746003875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746003875001907460038751907460038750190746003875

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Contacts#

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

Regulatory Flags#

DUNS number
044668515
Device count
1
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
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
00190746170829Separators854-034080854-0340802021-06-11
00190746189258Buccal Tubes851-110851-1102022-03-24
00190746189272Buccal Tubes851-121851-1212022-03-24
00190746189432Buccal Tubes851-182851-1822022-03-24
00190746141249Stainless Steel Brackets002-0070HMURWF002-0070HMURWF2021-09-03
00190746141263Stainless Steel Brackets002-0071HMULWF002-0071HMULWF2021-09-03
00190746141454Stainless Steel Brackets002-477HDLLWF002-477HDLLWF2021-09-03
00190746141461Stainless Steel Brackets002-477HDLRWF002-477HDLRWF2021-09-03
00190746141515Stainless Steel Brackets002-494HDLLWF002-494HDLLWF2021-09-03
00190746141522Stainless Steel Brackets002-494HDLRWF002-494HDLRWF2021-09-03
00190746175442Stainless Steel Brackets092-208BUL092-208BUL2021-09-03
00190746175459Stainless Steel Brackets092-208BUR092-208BUR2021-09-03
00190746176296Stainless Steel Brackets097-211UL097-211UL2021-09-03
00190746176302Stainless Steel Brackets097-211UR097-211UR2021-09-03
00190746177996Stainless Steel Brackets593-004593-0042021-09-03
00190746161575Stainless Steel Brackets091-142BUL091-142BUL2021-08-26
00190746174957Stainless Steel Brackets091-142BUR091-142BUR2021-08-26
00190746175268Stainless Steel Brackets092-006BUL092-006BUL2021-08-26
00190746175275Stainless Steel Brackets092-006BUR092-006BUR2021-08-26
00190746175503Stainless Steel Brackets092-444HDLR092-444HDLR2021-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944S01520300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480005C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30