Chrysalis Intelligence · Sponsors · Truabutment, Inc.

Truabutment, Inc.

Irvine, CA, US · 12 510(k) clearances · 1 recalls

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Total clearances

12

2020-01-29 → 2025-07-03

Last 12 months

0

Product codes

2

Most recent

2025-07-03

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	9	2024-10-09
DZE	Implant, Endosseous, Root-Form	Class II	Dental	3	2025-07-03

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2023-12-27

Date	Severity	Status	Recall #	Product	Code	Reason
2023-12-27	Class II	Ongoing	Z-1313-2025	Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN…	—	Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

Filings

All 510(k) clearances (12)

Date	K-number	Device	Code	Class	Specialty
2025-07-03	K243255	URIS Long Implant & Abutments	DZE	Class II	Dental
2024-10-09	K241485	TruAbutment DS; TruBase	NHA	Class II	Dental
2023-12-29	K230438	URIS Smart Path Implant System & Prosthetic	DZE	Class II	Dental
2023-10-30	K231874	AOT & T-L Abutment	NHA	Class II	Dental
2022-07-14	K213961	TruAbutment DS, TruBase	NHA	Class II	Dental
2021-09-15	K203649	TruAbutment DS, TruBase	NHA	Class II	Dental
2021-07-08	K202579	TruAbutment DS, TruBase	NHA	Class II	Dental
2021-06-04	K201842	TruBase S	NHA	Class II	Dental
2021-03-26	K201197	TruAbutment DS, TruBase S	NHA	Class II	Dental
2020-10-07	K200817	URIS OMNI Narrow System & Prosthetic	DZE	Class II	Dental
2020-06-19	K191913	TruAbutment DS	NHA	Class II	Dental
2020-01-29	K183106	TruAbutment DS	NHA	Class II	Dental