DIO Biotite-H Implant Systems
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of…
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
15manufacturers in China registered for this device type
263catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | DIO Corporation, South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K070570 |
| Record published | 2016-01-21 |
| Record revised | 2022-02-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 1 to 30 °C |
| Distribution end date | 2022-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSC 2008 | Ø8.5X2.0mm TORX | In distribution |
| SSC 2012H | Ø11.5X2.0mm HEX | In distribution |
| SSC 2008H | Ø8.5X2.0mm HEX | In distribution |
| SAS 5844 | Ø5.8X4.0(4.0)mm | Withdrawn |
| SAS 4216 | Ø4.2X6.0(1.0)mm | Withdrawn |
| SAS 3946 | Ø3.9X6.0(4.0)mm | Withdrawn |
| SSG 2015 | Ø2.0X15.0mm | Withdrawn |
| SAS 5216 | Ø5.2X6.0(1.0)mm | Withdrawn |
| SAS 3944 | Ø3.9X4.0(4.5)mm | Withdrawn |
| SAS 3918 | Ø3.9X8.0(1.0)mm | Withdrawn |
| SASA 4808 | Ø4.8X8.0mm | Withdrawn |
| SASC 5808 | Ø5.8X8.0mm | Withdrawn |
| SSG 1820 | Ø1.8X20.0mm | Withdrawn |
| SAC 4814N | Ø4.8X4(1)mm NON | Withdrawn |
| SAS 5828 | Ø5.8X8.0(2.0)mm | Withdrawn |
| SAS 3948 | Ø3.9X8.0(4.0)mm | Withdrawn |
| SCA 4514N | Ø4.5X14.2mm | Withdrawn |
| SAS 5816 | Ø5.8X6.0(1.0)mm | Withdrawn |
| SIP 4813N | Ø4.8X13.0mm | Withdrawn |
| SAC 3964N | Ø3.9X4(6)mm NON | Withdrawn |
| SAS 4816 | Ø4.8X6.0(1.0)mm | Withdrawn |
| SAC 3964T | Ø3.9X4(6)mm TORX | Withdrawn |
| SAS 4864 | Ø4.8X4.0(6.0)mm | Withdrawn |
| SAS 5218 | Ø5.2X8.0(1.0)mm | Withdrawn |
| SIP 4810N | Ø4.8X10.0mm | Withdrawn |
| SAC 4846T | Ø4.8X6(4)mm TORX | Withdrawn |
| SSC 1812 | Ø11.5X1.8mm TORX | Withdrawn |
| SIP 3910T | Ø3.9X10.0mm | Withdrawn |
| SIP 4813T | Ø4.8X13.0mm | Withdrawn |
| SAC 3944N | Ø3.9X4(4)mm NON | Withdrawn |
| SAS 4844 | Ø4.8X4.0(4.0)mm | Withdrawn |
| SASP 3910S | Ø3.9X10.0mm | Withdrawn |
| SAA 48325 | Ø4.8X25°(3.0)mm | Withdrawn |
| SAB 3904 | Ø3.9X4.0mm | Withdrawn |
| SAH 4024T | Ø4.0X4.0mm | Withdrawn |
| SAS 3964 | Ø3.9X4.0(6.0)mm | Withdrawn |
| SAA 48315A | Ø4.8X15°(3.0)mm TORX | Withdrawn |
| SAB 4504 | Ø4.5X4.0mm | Withdrawn |
| SAS 4814 | Ø4.8X4.0(1.0)mm | Withdrawn |
| SASA 5806 | Ø5.8X6.0mm | Withdrawn |
| SAS 3618 | Ø3.6X8.0(1.0)mm | Withdrawn |
| SAC 5846N | Ø5.8X6(4)mm NON | Withdrawn |
| SAS 5868 | Ø5.8X8.0(6.0)mm | Withdrawn |
| SSC 1808 | Ø8.5X1.8mm TORX | Withdrawn |
| SAC 5826N | Ø5.8X6(2)mm NON | Withdrawn |
| SSC 2008 | Ø8.5X2.0mm TORX | Withdrawn |
| SAA 58315A | Ø5.8X15°A(3.0)mm TORX | Withdrawn |
| SASA 5808 | Ø5.8X8.0mm | Withdrawn |
| SAC 4826T | Ø4.8X6(2)mm TORX | Withdrawn |
| SAS 4846 | Ø4.8X6.0(4.0)mm | Withdrawn |
| SAS 3938 | Ø3.9X8.0(3.0)mm | Withdrawn |
| SAC 4864N | Ø4.8X4(6)mm NON | Withdrawn |
| SABA 3510 | Ø5.0X4.0mm | Withdrawn |
| SAC 3934N | Ø3.9X4(3)mm NON | Withdrawn |
| SAB 4502 | Ø4.5X2.0mm | Withdrawn |
| SAC 3934T | Ø3.9X4.0mm | Withdrawn |
| SAA 39125A | Ø3.9X25°(1.5)mm TORX | Withdrawn |
| SMA 4514T | Ø4.5X14.7mm TORX | Withdrawn |
| SIP 3907N | Ø3.9X7.0mm | Withdrawn |
| SAC 3926N | Ø3.9X6(2)mm NON | Withdrawn |
| SAF 3812 | Ø3.8X12.0mm | Withdrawn |
| SAS 5214 | Ø5.2X4.0(1.0)mm | Withdrawn |
| SAG 3910N | Ø3.9X10.0mm | Withdrawn |
| SSC 1812H | Ø11.5X1.8mm HEX | Withdrawn |
| SASC 3904 | Ø3.9X4.0mm | Withdrawn |
| SAS 4848 | Ø4.8X8.0(4.0)mm | Withdrawn |
| SAC 4844N | Ø4.8X4(4)mm NON | Withdrawn |
| SSC 2012 | Ø11.5X2.0mm TORX | Withdrawn |
| SASA 4804 | Ø4.8X4.0mm | Withdrawn |
| SAC 4816T | Ø4.8X6(1)mm TORX | Withdrawn |
| SAC 4814T | Ø4.8X4(1)mm TORX | Withdrawn |
| SAC 3916T | Ø3.9X6.0mm | Withdrawn |
| SAS 4238 | Ø4.2X8.0(3.0)mm | Withdrawn |
| SAC 5846T | Ø5.8X6(4)mm TORX | Withdrawn |
| SAG 4810T | Ø4.8X10mm TORX | Withdrawn |
| SAC 5824T | Ø5.8X4(2)mm TORX | Withdrawn |
| SAS 5814 | Ø5.8X4.0(1.0)mm | Withdrawn |
| SAC 3946T | Ø3.9X6(4)mm TORX | Withdrawn |
| SAS 3924 | Ø3.9X4.0(2.0)mm | Withdrawn |
| SAT 4810T | Ø4.8X10.0mm | Withdrawn |
| SIT 5810T | Ø5.8X10.0mm | Withdrawn |
| SAC 4866N | Ø4.8X6(6)mm NON | Withdrawn |
| SAA 39315 | Ø3.9X15°(3.0)mm | Withdrawn |
| SAA 58125A | Ø5.8X25°A(1.5)mm TORX | Withdrawn |
| SASC 4806 | Ø4.8X6.0mm | Withdrawn |
| SAA 48115B | Ø4.8X15°(1.5)mm TORX | Withdrawn |
| SAC 5826T | Ø5.8X6(2)mm TORX | Withdrawn |
| SSC 2008H | Ø8.5X2.0mm HEX | Withdrawn |
| SCA 4514T | Ø4.5X14.2mm TORX | Withdrawn |
| SAC 5844N | Ø5.8X4(4)mm NON | Withdrawn |
| SAA 58325 | Ø5.8X25°(3.0)mm | Withdrawn |
| SAT 3910N | Ø3.9X10.0mm | Withdrawn |
| SAC 3936N | Ø3.9X6(3)mm NON | Withdrawn |
| SAS 4828 | Ø4.8X8.0(2.0)mm | Withdrawn |
| SAC 3936T | Ø3.9X6(3)mm TORX | Withdrawn |
| SIP 5807N | Ø5.8X7.0mm | Withdrawn |
| SAC 3924N | Ø3.9X4(2)mm NON | Withdrawn |
| SIT 4813S | Ø2.0X10.0mm | Withdrawn |
| SAB 3902 | Ø3.9X2.0mm | Withdrawn |
| SAC 4816N | Ø4.8X6(1)mm NON | Withdrawn |
| SAC 4834T | Ø4.8X4(3)mm TORX | Withdrawn |
| SAH 5038T | Ø5.0X8.0(3.0)mm | Withdrawn |
| SASC 3906 | Ø3.9X6.0mm | Withdrawn |
| SAC 4824N | Ø4.8X4(2)mm NON | Withdrawn |
| SAS 3936 | Ø3.9X6.0(3.0)mm | Withdrawn |
| SAC 5836N | Ø5.8X6(3)mm NON | Withdrawn |
| SIT 3910N | Ø3.9X10.0mm | Withdrawn |
| SAT 4810N | Ø4.8X10.0mm | Withdrawn |
| SIT 4810T | Ø4.8X10.0mm | Withdrawn |
| SAA 58115A | Ø5.8X15°A(1.5)mm TORX | Withdrawn |
| SAA 58325A | Ø5.8X25°(3.0)mm TORX | Withdrawn |
| SAS 5234 | Ø5.2X4.0(3.0)mm | Withdrawn |
| SASA 5804 | Ø5.8X4.0mm | Withdrawn |
| SAS 4234 | Ø4.2X4.0(3.0)mm | Withdrawn |
| SASA 3904 | Ø3.9X4.0mm | Withdrawn |
| SIP 3913T | Ø3.9X13.0mm | Withdrawn |
| SAA 39325B | Ø3.9X25°(3.0)mm TORX | Withdrawn |
| SIP 3913N | Ø3.9X13.0mm | Withdrawn |
| SAS 4836 | Ø4.8X6.0(3.0)mm | Withdrawn |
| SAS 3638 | Ø3.6X8.0(3.0)mm | Withdrawn |
| SIT 4810S | Ø2.0X10.0mm | Withdrawn |
| SAA 39315B | Ø3.9X15°(3.0)mm TORX | Withdrawn |
| SAS 3928 | Ø3.9X8.0(2.0)mm | Withdrawn |
| SASC 5806 | Ø5.8X6.0mm | Withdrawn |
| SAT 5810N | Ø5.8X10.0mm | Withdrawn |
| SAS 3966 | Ø3.9X6.0(6.0)mm | Withdrawn |
| SIT 3910T | Ø3.9X10.0mm | Withdrawn |
| SAC 4834N | Ø4.8X4(3)mm NON | Withdrawn |
| SAC 5816N | Ø5.8X6(1)mm NON | Withdrawn |
| SAC 3926T | Ø3.9X6(2)mm TORX | Withdrawn |
| SAC 5814N | Ø5.8X4(1)mm NON | Withdrawn |
| SAA 39325 | Ø3.9X25°(3.0)mm | Withdrawn |
| SASC 4804 | Ø4.8X4.0mm | Withdrawn |
| SIT 3910S | Ø1.8X10.0mm | Withdrawn |
| SAG 4810N | Ø4.8X10.0mm | Withdrawn |
| SAA 39315A | Ø3.9X15°(3.0)mm TORX | Withdrawn |
| SAS 4866 | Ø4.8X6.0(6.0)mm | Withdrawn |
| SAS 3934 | Ø3.9X4.0(3.0)mm | Withdrawn |
| SASP 3910B | Ø3.9X10.0mm | Withdrawn |
| SIP 5813T | Ø5.8X13.0mm | Withdrawn |
| SAC 3944T | Ø3.9X4.0mm | Withdrawn |
| SASA 3906 | Ø3.9X6.0mm | Withdrawn |
| SAC 5864N | Ø5.8X4(6)mm NON | Withdrawn |
| SAC 4824T | Ø4.8X4(2)mm TORX | Withdrawn |
| SAS 4824 | Ø4.8X4.0(2.0)mm | Withdrawn |
| SIP 5807T | Ø5.8X7.0mm | Withdrawn |
| SAC 3966T | Ø3.9X6(6)mm TORX | Withdrawn |
| SIP 3910N | Ø3.9X10.0mm | Withdrawn |
| SASP 4810B | Ø4.8X10.0mm | Withdrawn |
| SAS 5826 | Ø5.8X6.0(2.0)mm | Withdrawn |
| SMA 4514N | Ø4.5X14.7mm | Withdrawn |
| SAA 48315B | Ø4.8X15°(3.0)mm TORX | Withdrawn |
| SAC 5834T | Ø5.8X4(3)mm TORX | Withdrawn |
| SAA 58125 | Ø5.8X25°(1.5)mm | Withdrawn |
| SMA 5515N | Ø5.5X15.3mm | Withdrawn |
| SIP 5810T | Ø5.8X10.0mm | Withdrawn |
| SMA 5015T | Ø5.3X15.3mm TORX | Withdrawn |
| SAA 48125 | Ø4.8X25°(1.5)mm | Withdrawn |
| SIP 3907T | Ø3.9X7.0mm | Withdrawn |
| SAC 5816T | Ø5.8X6(1)mm TORX | Withdrawn |
| SAA 58115 | Ø5.8X15°(1.5)mm | Withdrawn |
| SAC 4836T | Ø4.8X6(3)mm TORX | Withdrawn |
| SAC 4866T | Ø4.8X6(6)mm TORX | Withdrawn |
| SASA 3908 | Ø3.9X8.0mm | Withdrawn |
| SASC 3908 | Ø3.9X8.0mm | Withdrawn |
| SAA 39125B | Ø3.9X25°(1.5)mm TORX | Withdrawn |
| SAS 5838 | Ø5.8X8.0(3.0)mm | Withdrawn |
| SAS 3616 | Ø3.6X6.0(1.0)mm | Withdrawn |
| SAS 5824 | Ø5.8X4.0(2.0)mm | Withdrawn |
| SAC 3924T | Ø3.9X4.0mm | Withdrawn |
| SAT 3910T | Ø3.9X10.0mm | Withdrawn |
| SIP 4810T | Ø4.8X10.0mm | Withdrawn |
| SSG 1815 | Ø1.8X15.0mm | Withdrawn |
| SMA 5515T | Ø5.5X15.3mm TORX | Withdrawn |
| SAC 4864T | Ø4.8X4(6)mm TORX | Withdrawn |
| SAC 3914T | Ø3.9X4.0mm | Withdrawn |
| SCA 4014T | Ø4.0X14.2mm TORX | Withdrawn |
| SAA 48115 | Ø4.8X15°(1.5)mm | Withdrawn |
| SAA 58115B | Ø5.8X15°A(1.5)mm TORX | Withdrawn |
| SAC 4836N | Ø4.8X6(3)mm NON | Withdrawn |
| SAS 4834 | Ø4.8X4.0(3.0)mm | Withdrawn |
| SAS 5238 | Ø5.2X8.0(3.0)mm | Withdrawn |
| SASC 4808 | Ø4.8X8.0mm | Withdrawn |
| SSC 1808H | Ø8.5X1.8mm HEX | Withdrawn |
| SAA 39115 | Ø3.9X15°(1.5)mm | Withdrawn |
| SAA 58125B | Ø5.8X25°A(1.5)mm TORX | Withdrawn |
| SAS 5834 | Ø5.8X4.0(3.0)mm | Withdrawn |
| SAS 4214 | Ø4.2X4.0(1.0)mm | Withdrawn |
| SAS 5818 | Ø5.8X8.0(1.0)mm | Withdrawn |
| SAS 5836 | Ø5.8X6.0(3.0)mm | Withdrawn |
| SAF 4512 | Ø4.5X12.0mm | Withdrawn |
| SIT 3913S | Ø1.8X10.0mm | Withdrawn |
| SAA 48325A | Ø4.8X25°(3.0)mm TORX | Withdrawn |
| SAC 5824N | Ø5.8X4(2)mm NON | Withdrawn |
| SMA 6015N | Ø5.95X15.3mm | Withdrawn |
| SAA 48325B | Ø4.8X25°(3.0)mm TORX | Withdrawn |
| SAS 4838 | Ø4.8X8.0(3.0)mm | Withdrawn |
| SMA 5015N | Ø5.3X15.3mm | Withdrawn |
| SAT 5810T | Ø5.8X10.0mm | Withdrawn |
| SSG 2010 | Ø2.0X10.0mm | Withdrawn |
| SMA 6513N | Ø6.5X13.3mm | Withdrawn |
| SAC 3966N | Ø3.9X6(6)mm NON | Withdrawn |
| SAA 48315 | Ø4.8X15°(3.0)mm | Withdrawn |
| SIT 5810N | Ø5.8X10.0mm | Withdrawn |
| SIP 5810N | Ø5.8X10.0mm | Withdrawn |
| SAA 58315 | Ø5.8X15°(3.0)mm | Withdrawn |
| SAC 5844T | Ø5.8X4(4)mm TORX | Withdrawn |
| SAS 5846 | Ø5.8X6.0(4.0)mm | Withdrawn |
| SAA 39115A | Ø3.9X15°A(1.5)mm TORX | Withdrawn |
| SAS 4868 | Ø4.8X8.0(6.0)mm | Withdrawn |
| SAC 5836T | Ø5.8X6(3)mm TORX | Withdrawn |
| SIP 5813N | Ø5.8X13.0mm | Withdrawn |
| SAS 5848 | Ø5.8X8.0(4.0)mm | Withdrawn |
| SAC 4826N | Ø4.8X6(2)mm NON | Withdrawn |
| SAS 5864 | Ø5.8X4.0(6.0)mm | Withdrawn |
| SSG 1810 | Ø1.8X10.0mm | Withdrawn |
| SAC 5814T | Ø5.8X4(1)mm TORX | Withdrawn |
| SAS 3636 | Ø3.6X6.0(3.0)mm | Withdrawn |
| SAS 3634 | Ø3.6X4.0(3.0)mm | Withdrawn |
| SAH 5024T | Ø5.0X4.0(2.0)mm | Withdrawn |
| SAA 39115B | Ø3.9X15°B(1.5)mm TORX | Withdrawn |
| SAC 5864T | Ø5.8X4(6)mm TORX | Withdrawn |
| SASC 5804 | Ø5.8X4.0mm | Withdrawn |
| SAS 3614 | Ø3.6X4.0(1.0)mm | Withdrawn |
| SAA 48125B | Ø4.8X25°(1.5)mm TORX | Withdrawn |
| SASP 4810S | Ø4.8X10.0mm | Withdrawn |
| SSC 2012H | Ø11.5X2.0mm HEX | Withdrawn |
| SAC 4844T | Ø4.8X4(4)mm TORX | Withdrawn |
| SAS 4826 | Ø4.8X6.0(2.0)mm | Withdrawn |
| SAS 3926 | Ø3.9X6.0(2.0)mm | Withdrawn |
| SMA 4014T | Ø4.0X14.7mm TORX | Withdrawn |
| SAS 4218 | Ø4.2X8.0(1.0)mm | Withdrawn |
| SAS 5236 | Ø5.2X6.0(3.0)mm | Withdrawn |
| SAA 58315B | Ø5.8X15°A(3.0)mm TORX | Withdrawn |
| SMA 6513T | Ø6.5X13.3mm TORX | Withdrawn |
| SAC 3914N | Ø3.9X4(1)mm NON | Withdrawn |
| SAS 4818 | Ø4.8X8.0(1.0)mm | Withdrawn |
| SASA 4806 | Ø4.8X6.0mm | Withdrawn |
| SAS 3916 | Ø3.9X6.0(1.0)mm | Withdrawn |
| SSG 2020 | Ø2.0X20.0mm | Withdrawn |
| SAC 5866N | Ø5.8X6(6)mm NON | Withdrawn |
| SMA 4014N | Ø4.0X14.7mm | Withdrawn |
| SAC 3916N | Ø3.9X6(1)mm NON | Withdrawn |
| SAS 4236 | Ø4.2X6.0(3.0)mm | Withdrawn |
| SMA 6015T | Ø5.95X15.3mm TORX | Withdrawn |
| SCA 4014N | Ø4.0X14.2mm | Withdrawn |
| SAC 4846N | Ø4.8X6(4)mm NON | Withdrawn |
| SIP 4807N | Ø4.8X7.0mm | Withdrawn |
| SIT 4810N | Ø4.8X10.0mm | Withdrawn |
| SIP 4807T | Ø4.8X7.0mm | Withdrawn |
Showing 250 of 263 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220253 | 2023-08-18 |
| K193404 | 2020-05-18 |
| K192263 | 2020-02-21 |
| K190048 | 2019-09-30 |
| K181037 | 2018-12-21 |
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.