TPLC - Total Product Life Cycle

• Device: material, impression
• Regulation Description: Impression material.
• Product Code: ELW
• Regulation Number: 872.3660
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
B&E KOREA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING OKVD BIOLOGICAL TECHNOLOGY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHEMOMENT MATERIALS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
COLTÈNE/WHALEDENT AG
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	SUBSTANTIALLY EQUIVALENT	2
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HDI, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYGEDENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SAN. VE TIC. A.S.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE PRODUCT BRANDS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANCHANG DENTAL BRIGHT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NO STRESS IMPRESS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VIGODENT INDÚSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	6	6
2022	9	9
2023	13	13
2024	3	3
2025	24	24

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	42	42
Adverse Event Without Identified Device or Use Problem	11	11
Improper or Incorrect Procedure or Method	3	3
Off-Label Use	2	2
Difficult to Remove	2	2
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Dyspnea	2	2
Swelling/ Edema	2	2
Obstruction/Occlusion	1	1
Tooth Fracture	1	1
Rash	1	1
Swelling	1	1
Discomfort	1	1
Reaction	1	1
Sore Throat	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinician's Choice Dental Products Inc.	II	May-17-2022