FDA.reportPublic FDA data

Propel

Primary DI
00852673007073
Brand
Propel
Company
PROPEL ORTHODONTICS LLC
Model
ASM-20021
Catalog number
ASM-20021
Device description
Packaged C-Shaped Mouthpiece, Tapered, Assy
Published
2018-03-06
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
ECRSetter, Band, Orthodontic
OYHOrthodontic Vibratory Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1
OYHOrthodontic Vibratory AccessoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852673007073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852673007073008526730070738526730070730852673007073

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
408 394 5851bw@propelortho.com

Regulatory Flags#

DUNS number
117334253
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852673007103VProASM-200182020-03-23
00852673007240Acceledent OptimaASM-200312020-07-31
00852673007004PropelASM-20010ASM-200102016-12-28
00852673007189VPro+ASM-200232020-03-17
00852673007127HyperByteASM-20018-052020-01-14
00852673007011PropelASM-20018ASM-200182016-12-28
00852673007028PropelASM-20010-04ASM-20010-042016-12-28
00852673007035PropelASM-20010-01ASM-20010-012016-12-28
00852673007042PropelASM-20010-03ASM-20010-032016-12-28
00852673007059PropelASM-20010-02ASM-20010-022016-12-28
00852673007066PropelASM-20022ASM-200222018-03-06
00852673007080PropelASM-20018-04ASM-20018-042018-03-09
00852673007097PropelASM-200232018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014476143SmileSet Aligner/Retainer Seater/Removal ToolOrtho Dental Lab LLCECR2025-10-16
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 PackOrtho Dental Lab LLCECR2025-10-01
00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022967PDT, Inc.PDT, INC.ECR2024-07-05
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420843Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420935Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420942Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420959Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420833Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420840Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420925Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420932Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420949Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF19080120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-29
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
D001V181001SureSmileDentsply International Inc.OYH2022-11-11
D001V181021SureSmileDentsply International Inc.OYH2022-11-11
D001V181151ByteDentsply International Inc.OYH2022-11-11
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03