Artegral Life

Living mould chart artegral life in shade A3 containing: 20 upper and 13 lower anterior sets, 5 upper and 5 lower posterior sets

Registry build 21.09.26
26manufacturers in China registered for this device type
861catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELM
Manufacturer City Province Registered as Device types
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Fuzhou Delphin BIO-Tech Co., Ltd. Fuzhou Fujian Manufacturer 18
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Improve Co., Limited Lantau Island Hong Kong Contract manufacturer 16
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Heyuan HEY White Technology Co., Ltd. Heyuan Guangdong Manufacturer 12
Beijing Yingguan Dental Science&Technology Co., Ltd. Beijing Beijing Manufacturer 11
Smile Dental Laboratory Company Limited Zhuhai Guangdong Manufacturer 11

Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth

Record

Regulatory record for artegral life
Listed by Merz Dental Gmbh, Germany
FDA product code ELM
Device type Denture, Plastic, Teeth
Device class Class 2
Regulation 21 CFR 872.3590
Establishment Manufacturer
510(k) K030588
Record published 2017-09-30
Record revised 2025-12-22 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for artegral life
Catalogue number Size Status
anteriors; shade BL2; mould BM In distribution
anteriors; shade B1; mould CL In distribution
posteriors; shade A3; size XS; upper jaw In distribution
posteriors; shade C2; size XS; lower jaw In distribution
anteriors; shade BL2; mould BOM In distribution
anteriors; shade B3; mould BOL In distribution
anteriors; shade C4; mould UBIS In distribution
anteriors; shade C2; mould UCL In distribution
anteriors; shade BL2; mould UIS In distribution
anteriors; shade A3.5; mould BS In distribution
anteriors; shade A1; mould BOM In distribution
anteriors; shade A2; mould ITM In distribution
posteriors; shade B2; size L; upper jaw In distribution
anteriors; shade A1; mould IXL In distribution
posteriors; shade A1; size M; upper jaw In distribution
anteriors; shade C2; mould IXL In distribution
anteriors; shade B1; mould BOM In distribution
anteriors; shade A3.5; mould BL In distribution
posteriors; shade A3; size S; lower jaw In distribution
anteriors; shade C1; mould BIL In distribution
anteriors; shade C4; mould UBS In distribution
anteriors; shade B4; mould BOL In distribution
posteriors; shade C1; size XL; upper jaw In distribution
posteriors; shade A3; size L; upper jaw In distribution
anteriors; shade BL1; mould UCM In distribution
posteriors; shade BL1; size XS; upper jaw In distribution
anteriors; shade C3; mould IS In distribution
anteriors; shade C2; mould UCM In distribution
anteriors; shade D2; mould CS In distribution
posteriors; shade A3; size XS; lower jaw In distribution
anteriors; shade BL4; mould BIS In distribution
posteriors; shade C2; size XL; lower jaw In distribution
anteriors; shade B4; mould BM In distribution
posteriors; shade A1; size XL; lower jaw In distribution
posteriors; shade B1; size L; lower jaw In distribution
anteriors; shade B4; mould BIL In distribution
anteriors; shade B4; mould ITS In distribution
anteriors; shade D2; mould UBIM In distribution
posteriors; shade B4; size XL; upper jaw In distribution
anteriors; shade B3; mould ITS In distribution
posteriors; shade B3; size L; lower jaw In distribution
anteriors; shade C1; mould BOM In distribution
anteriors; shade A4; mould BL In distribution
anteriors; shade BL1; mould UBIM In distribution
posteriors; shade A1; size XL; upper jaw In distribution
anteriors; shade BL2; mould UIL In distribution
anteriors; shade B1; mould UBIM In distribution
anteriors; shade C2; mould UIS In distribution
anteriors; shade C2; mould ITS In distribution
anteriors; shade B2; mould ITM In distribution
anteriors; shade A3.5; mould BM In distribution
anteriors; shade D2; mould ITM In distribution
anteriors; shade D4; mould UIM In distribution
anteriors; shade BL3; mould BOS In distribution
posteriors; shade B2; size XL; lower jaw In distribution
anteriors; shade A3.5; mould BOM In distribution
anteriors; shade D4; mould CM In distribution
anteriors; shade BL2; mould ITL In distribution
anteriors; shade B3; mould UBXL In distribution
posteriors; shade A3.5; size M; lower jaw In distribution
anteriors; shade D3; mould BOL In distribution
anteriors; shade B4; mould UBL In distribution
anteriors; shade C4; mould ITM In distribution
posteriors; shade C3; size M; upper jaw In distribution
posteriors; shade D3; size XS; lower jaw In distribution
anteriors; shade A4; mould IXL In distribution
anteriors; shade B3; mould BIM In distribution
anteriors; shade C3; mould IM In distribution
anteriors; shade BL1; mould BIM In distribution
anteriors; shade B2; mould UBIM In distribution
posteriors; shade BL2; size S; upper jaw In distribution
anteriors; shade B2; mould BXL In distribution
anteriors; shade B1; mould ITM In distribution
anteriors; shade B3; mould IXL In distribution
anteriors; shade BL4; mould UBM In distribution
anteriors; shade A1; mould UCS In distribution
anteriors; shade B1; mould UBM In distribution
anteriors; shade A3; mould BIM In distribution
anteriors; shade B4; mould BS In distribution
anteriors; shade A4; mould BIL In distribution
anteriors; shade BL3; mould UBIL In distribution
anteriors; shade D2; mould UBIS In distribution
anteriors; shade BL2; mould UBIS In distribution
anteriors; shade A3; mould ITS In distribution
anteriors; shade C2; mould ITM In distribution
posteriors; shade B2; size M; lower jaw In distribution
anteriors; shade BL3; mould CL In distribution
anteriors; shade C1; mould BS In distribution
anteriors; shade A4; mould BOL In distribution
anteriors; shade D4; mould UIL In distribution
anteriors; shade A4; mould UBIS In distribution
anteriors; shade C1; mould IXL In distribution
anteriors; shade C4; mould BIM In distribution
posteriors; shade C2; size XS; upper jaw In distribution
anteriors; shade B1; mould UBXL In distribution
anteriors; shade D2; mould ITS In distribution
anteriors; shade BL2; mould BL In distribution
anteriors; shade BL3; mould BXL In distribution
anteriors; shade B4; mould UIS In distribution
anteriors; shade C3; mould BIL In distribution
posteriors; shade A3; size L; lower jaw In distribution
anteriors; shade B2; mould BM In distribution
anteriors; shade B3; mould UCL In distribution
anteriors; shade C1; mould ITM In distribution
anteriors; shade A1; mould IS In distribution
anteriors; shade BL3; mould BM In distribution
anteriors; shade A4; mould IL In distribution
anteriors; shade D3; mould BIM In distribution
anteriors; shade BL4; mould BOM In distribution
anteriors; shade A1; mould BOS In distribution
anteriors; shade A3; mould UIS In distribution
anteriors; shade B1; mould BIL In distribution
anteriors; shade A3.5; mould BIL In distribution
anteriors; shade A3; mould UCS In distribution
posteriors; shade BL2; size XL; upper jaw In distribution
anteriors; shade B4; mould UIM In distribution
anteriors; shade C3; mould UBIL In distribution
anteriors; shade D3; mould BIS In distribution
anteriors; shade BL1; mould UIM In distribution
anteriors; shade BL4; mould BOS In distribution
posteriors; shade B4; size S; upper jaw In distribution
anteriors; shade BL2; mould UCL In distribution
anteriors; shade B4; mould BIM In distribution
anteriors; shade C2; mould UIL In distribution
anteriors; shade D2; mould BOM In distribution
anteriors; shade A3.5; mould UBIL In distribution
anteriors; shade C1; mould UIM In distribution
anteriors; shade C4; mould BOS In distribution
posteriors; shade A1; size XS; lower jaw In distribution
posteriors; shade BL4; size XL; lower jaw In distribution
anteriors; shade D3; mould UBIS In distribution
anteriors; shade BL4; mould IXL In distribution
anteriors; shade BL1; mould BXL In distribution
posteriors; shade B3; size XL; upper jaw In distribution
anteriors; shade B4; mould BOS In distribution
anteriors; shade B4; mould UIL In distribution
posteriors; shade A3.5; size XL; lower jaw In distribution
anteriors; shade A1; mould UBL In distribution
anteriors; shade BL2; mould UBXL In distribution
anteriors; shade D4; mould CL In distribution
anteriors; shade BL1; mould CM In distribution
anteriors; shade B3; mould IL In distribution
anteriors; shade D3; mould IL In distribution
anteriors; shade B2; mould CS In distribution
anteriors; shade A2; mould IM In distribution
anteriors; shade A3.5; mould IXL In distribution
posteriors; shade A4; size XL; upper jaw In distribution
anteriors; shade B3; mould UCM In distribution
anteriors; shade D3; mould CM In distribution
anteriors; shade BL1; mould ITL In distribution
anteriors; shade BL3; mould UBIM In distribution
anteriors; shade B1; mould UCL In distribution
anteriors; shade C4; mould UBIM In distribution
anteriors; shade B1; mould BS In distribution
anteriors; shade BL2; mould BIM In distribution
anteriors; shade A3; mould UBL In distribution
anteriors; shade BL2; mould ITS In distribution
anteriors; shade B1; mould IM In distribution
anteriors; shade A2; mould ITL In distribution
anteriors; shade B2; mould UBL In distribution
anteriors; shade C2; mould UBL In distribution
anteriors; shade D4; mould UCM In distribution
posteriors; shade B4; size XS; lower jaw In distribution
posteriors; shade C1; size XL; lower jaw In distribution
posteriors; shade BL2; size L; upper jaw In distribution
anteriors; shade BL1; mould UBS In distribution
anteriors; shade BL4; mould BOL In distribution
anteriors; shade C1; mould IS In distribution
posteriors; shade C3; size XL; lower jaw In distribution
posteriors; shade BL3; size S; lower jaw In distribution
anteriors; shade A3; mould BXL In distribution
anteriors; shade A2; mould BOS In distribution
anteriors; shade A3.5; mould UBM In distribution
anteriors; shade C1; mould BL In distribution
anteriors; shade B4; mould BXL In distribution
anteriors; shade D2; mould CL In distribution
anteriors; shade C3; mould UBIS In distribution
anteriors; shade A3; mould CS In distribution
anteriors; shade D4; mould ITS In distribution
anteriors; shade A4; mould ITL In distribution
anteriors; shade A4; mould UBXL In distribution
posteriors; shade A1; size XS; upper jaw In distribution
posteriors; shade A4; size XL; lower jaw In distribution
anteriors; shade D2; mould UBL In distribution
anteriors; shade BL1; mould BM In distribution
anteriors; shade C3; mould UBL In distribution
anteriors; shade A2; mould BOM In distribution
anteriors; shade D4; mould BIS In distribution
anteriors; shade B4; mould ITM In distribution
anteriors; shade A2; mould CL In distribution
anteriors; shade D2; mould UCS In distribution
anteriors; shade B1; mould CS In distribution
anteriors; shade B3; mould ITM In distribution
anteriors; shade BL4; mould BM In distribution
anteriors; shade B4; mould IM In distribution
anteriors; shade A2; mould IS In distribution
anteriors; shade BL4; mould ITS In distribution
anteriors; shade BL1; mould UCL In distribution
posteriors; shade A2; size XS; upper jaw In distribution
anteriors; shade A4; mould BS In distribution
posteriors; shade A3; size M; lower jaw In distribution
anteriors; shade BL2; mould BIL In distribution
anteriors; shade BL1; mould UBXL In distribution
anteriors; shade A3.5; mould UBIM In distribution
posteriors; shade A1; size L; upper jaw In distribution
anteriors; shade B3; mould BOM In distribution
posteriors; shade C4; size M; upper jaw In distribution
anteriors; shade C2; mould IL In distribution
anteriors; shade A3.5; mould ITM In distribution
anteriors; shade D3; mould UIL In distribution
anteriors; shade B3; mould IS In distribution
anteriors; shade C4; mould BIS In distribution
anteriors; shade BL1; mould UBL In distribution
anteriors; shade C1; mould UBS In distribution
anteriors; shade BL4; mould UIM In distribution
anteriors; shade B3; mould ITL In distribution
anteriors; shade C1; mould UBIM In distribution
anteriors; shade BL4; mould UCL In distribution
anteriors; shade B2; mould BL In distribution
anteriors; shade A1; mould UBM In distribution
anteriors; shade A2; mould BIS In distribution
anteriors; shade C3; mould BXL In distribution
anteriors; shade BL4; mould UBXL In distribution
posteriors; shade D3; size L; lower jaw In distribution
anteriors; shade C4; mould UBIL In distribution
anteriors; shade B1; mould CM In distribution
anteriors; shade D2; mould ITL In distribution
anteriors; shade B3; mould UBL In distribution
posteriors; shade A1; size S; upper jaw In distribution
anteriors; shade D3; mould BIL In distribution
anteriors; shade B2; mould UCL In distribution
anteriors; shade D3; mould CS In distribution
anteriors; shade BL1; mould ITM In distribution
posteriors; shade BL1; size M; lower jaw In distribution
anteriors; shade C2; mould BL In distribution
anteriors; shade D3; mould UIM In distribution
posteriors; shade A2; size L; lower jaw In distribution
anteriors; shade B4; mould UCM In distribution
anteriors; shade A3; mould UIM In distribution
anteriors; shade C1; mould ITL In distribution
anteriors; shade A2; mould UCM In distribution
posteriors; shade C1; size XS; lower jaw In distribution
anteriors; shade BL2; mould UBIM In distribution
anteriors; shade C2; mould CL In distribution
anteriors; shade BL2; mould UIM In distribution
anteriors; shade C4; mould BL In distribution
anteriors; shade A4; mould UBIM In distribution
anteriors; shade BL3; mould BIM In distribution
posteriors; shade D4; size S; upper jaw In distribution
anteriors; shade A1; mould UIL In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Resin Teeth DCL PE Ivoclar Vivadent Aktiengesellschaft 8,657
Primodent Polident d.o.o. 3,814
Resin Teeth S PE S DCL Ivoclar Vivadent Aktiengesellschaft 2,870
Vitapan Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 2,480
Myerson Special The Myerson Company Limited 2,386
Kenson The Myerson Company Limited 2,365
Candulor TCR Candulor, AG 1,944
Vita Physiodens Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 1,788
Portrait® IPN® Anteriors Dentsply LLC 1,674
Enigma Denture Teeth – Pairs Davis Schottlander & Davis, Ltd. 1,632
Ivostar Gnathostar Ivoclar Vivadent Aktiengesellschaft 1,501
REF-Line Polident d.o.o. 1,458

Showing 12 of 9,979. All products under Denture, Plastic, Teeth

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K120404 2012-05-21
K030588 2003-05-07

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer