FDA.reportPublic FDA data

BIO-RAY A-1 Anchor Screw System

Primary DI
04719873099733
Brand
BIO-RAY A-1 Anchor Screw System
Company
MICROWARE PRECISION CO., LTD.
Model
A-1HS-221510
Device description
A-1H Anchorage Screw, Ø1.5 x L10mm, Single Hook, Square Hole
Published
2026-05-12
Public version status
New
Distribution status
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
OATImplant, Endosseous, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182929000BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd.2019-11-06OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873099733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873099733047198730997334719873099733

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchoring screwA small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886424636275harrisondu@microware.com.tw

Regulatory Flags#

DUNS number
658650833
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719962166575Tandry Orthopedic Manual Surgical Instrument303027A-5002025-11-12
04719962166599Tandry Orthopedic Manual Surgical Instrument304001A-5002025-11-12
04719962169132Tandry Orthopedic Manual Surgical Instrument306011A-K002025-10-31
04719962169224Tandry Orthopedic Manual Surgical Instrument306050A-K002025-10-31
04719879398700Tandry Orthopedic Manual Surgical Instrument306045A-K002025-11-26
04719879398014Tandry Orthopedic Manual Surgical Instrument303005A-5002025-08-27
04719879398182Tandry Orthopedic Manual Surgical Instrument304007A-5002025-08-27
04719879398052Tandry Orthopedic Manual Surgical Instrument303012B-K002025-08-22
04719879398069Tandry Orthopedic Manual Surgical Instrument303013A-Z002025-08-22
04719879398113Tandry Orthopedic Manual Surgical Instrument303020A-K002025-08-22
04719879398199Tandry Orthopedic Manual Surgical Instrument304008A-K002025-08-22
04719879398229Tandry Orthopedic Manual Surgical Instrument304011A-Z002025-08-22
04719879398328Tandry Orthopedic Manual Surgical Instrument306027A-K002025-08-22
04719879398045Tandry Orthopedic Manual Surgical Instrument303012A-K002025-05-07
04719873099689BIO-RAY A-1 Anchor Screw SystemA-1H-2120082026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemA-1H-2120102026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemA-1H-2120122026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemA-1H-2120142026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemA-1HS-2220082026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemA-1HS-2220102026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873099689BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099696BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099702BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099719BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099757BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099764BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099771BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873099788BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100057BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100064BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100071BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100088BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100248BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100255BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100262BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100279BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873100286BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-15
04719873093021BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873098736BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099580BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099597BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099603BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099610BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099627BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099634BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099641BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099658BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099665BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099672BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12
04719873099726BIO-RAY A-1 Anchor Screw SystemMICROWARE PRECISION CO., LTD.OAT2026-05-12