T2Plus dental X-ray systems recalled over a missing certification statement
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 as a documentation issue: the record cites an omitted certification statement on the labeling, with no device defect or reported harm.
Plain-English summary
The Osstem Dental X-Ray System T2Plus, product models T2-C-P and T2-CS-P, is the subject of a voluntary medical device correction.
Osstem Implant states the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations), specifically the statement that the product complies with all applicable performance standards.
The correction covers products carrying UDI codes 08800000996059 and 08800000996042, distributed in the United States. The FDA has classified the action as Class II.
The enforcement record describes a missing labeling statement rather than a device defect, and reports no injuries. Sites operating an affected system should follow the firm's instructions.
The recalled product
- Product
- Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
- Manufacturer
- OSSTEM Implant Co., Ltd.
- Category
- Medical Device — Dental imaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI Codes: 08800000996059 and 08800000996042.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by OSSTEM Implant Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · OSSTEM Implant Co., Ltd.
See all →- LowDental X-ray systems recalled over a missing radiological certification statement
FDA (Devices) · 2025-11-12
- LowT2 dental X-ray systems recalled over an omitted certification statement
FDA (Devices) · 2025-11-12
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