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HS Cap

FDA UDI

Class I (US FDA UDI)

by Truabutment Korea Co., Ltd

Identity

Trade Name
HS Cap FDA UDI
Generic Name
Dental implant abutment analog, intraoral-scanning, reusable FDA UDI
Model / Reference
HS-GD47 FDA UDI

Identifiers

Primary DI / UDI-DI
08800076473140 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant abutment analog, intraoral-scanning, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental implant abutment analog, intraoral-scanning, reusable

HS Cap by Truabutment Korea Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant abutment analog, intraoral-scanning, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Truabutment Korea Co., Ltd

Sources (1)

  • FDA UDI 7ba688d5-0b99-4f4b-9e15-a950f13e323e 32 fields · synced Jun 6, 2026