FDA.reportPublic FDA data

METAL SELF- LIGATING Tube 022 MBT LL6

Primary DI
06970469418866
Brand
METAL SELF- LIGATING Tube 022 MBT LL6
Company
Zhejiang Headway Medical Equipment Co., Ltd
Model
HS203-2236-1-V
Device description
PK OF 5
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970469418866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970469418866069704694188666970469418866

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method
Sound Waves

Regulatory Flags#

DUNS number
412892520
Device count
1
Premarket exempt
true
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
16970469419273KLOwenBRSLKT2026-04-23
0697046941851402X KLO Metal Self-Ligating +5.2BR02X-V2025-11-26
0697046941852103X KLO Metal Self-Ligating +5.4BR03X-V2025-11-26
0697046941853804X KLO Metal Self-Ligating +15.0BR04X-V2025-11-26
0697046941854505X KLO Metal Self-Ligating +15.2BR05X-V2025-11-26
0697046941855206X KLO Metal Self-Ligating +15.4BR06X-V2025-11-26
0697046941856907X KLO Metal Self-Ligating -5.0BR07X-V2025-11-26
0697046941857608X KLO Metal Self-Ligating -5.2BR08X-V2025-11-26
0697046941858309X KLO Metal Self-Ligating -5.4BR09X-V2025-11-26
0697046941859010X KLO Metal Self-Ligating -15.0BR10X-V2025-11-26
0697046941860611X KLO Metal Self-Ligating -15.2BR11X-V2025-11-26
0697046941861312X KLO Metal Self-Ligating -15.4BR12X-V2025-11-26
0697046941862013X KLO Metal Self-Ligating -25.0BR13X-V2025-11-26
0697046941863714X KLO Metal Self-Ligating -25.2BR14X-V2025-11-26
0697046941864415X KLO Metal Self-Ligating -25.4BR15X-V2025-11-26
0697046941865116X KLO Metal Self-Ligating Narrow +5.0 BR16X-V2025-11-26
0697046941866817X KLO Metal Self-Ligating Narrow +5.2 BR17X-V2025-11-26
0697046941867518X KLO Metal Self-Ligating Narrow +5.4BR18X-V2025-11-26
0697046941868219X KLO Metal Self-Ligating Narrow +15.0BR19X-V2025-11-26
0697046941869920X KLO Metal Self-Ligating Narrow +15.2BR20X-V2025-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25